Tool · Post-Market Surveillance
PSUR Report
The vigilance database section of your PSUR, generated in seconds: FDA MAUDE adverse event trends, recalls, and enforcement classifications for your device and similar devices — with the documented, reproducible methodology auditors ask for.
Reporting period 2024-07 – 2026-06 · FDA data refreshed ~monthly
Product Code: FRN
FDA class 2
Pump, Infusion
Adverse events in period
102,382
-70% vs. prior period (342,271)
Deaths reported
173
Recalls in period
66
Class I enforcement
30
Adverse events per month
2024-07 – 2026-06Loading...
Events by type
Period vs. prior periodLoading...
Event type
Period
Prior
Death
173
208
Injury
1,301
1,576
Malfunction
100,882
340,448
Other
26
28
Not specified
0
11
Most reported coded problems
Top 15Product problems
Count
Device Sensing Problem
14,898
Break
11,315
Device Alarm System
8,612
Failure to Sense
7,828
Corroded
7,380
No Apparent Adverse Event
6,537
Failure to Infuse
5,702
Contamination
4,792
Crack
4,769
Calibration Problem
3,910
Improper Flow or Infusion
3,495
Circuit Failure
2,673
Display Difficult to Read
2,581
Excess Flow or Over-Infusion
2,505
Protective Measures Problem
2,174
Patient problems
Count
No Clinical Signs, Symptoms or Conditions
97,208
Insufficient Information
2,310
Hyperglycemia
1,641
Low Blood Pressure/ Hypotension
406
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
194
Hypoglycemia
152
High Blood Pressure/ Hypertension
123
Hemorrhage/Blood Loss/Bleeding
78
Cardiac Arrest
72
Pain
54
Tachycardia
44
Headache
39
Malaise
36
Nausea
35
Dizziness
34
Recalls in period
66 total
FDA enforcement classification:
Class I: 30
Class II: 37
Class III: 1
Date
Recalling firm
Status
Reason
2026-05-06
Open, Classified
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
2026-05-06
Open, Classified
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
2026-04-29
Open, Classified
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
2026-04-29
Open, Classified
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
2026-04-29
Open, Classified
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
2026-02-11
Open, Classified
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
2026-02-04
Open, Classified
Potential for the Cassette Loading Lever to break.
2026-01-13
Open, Classified
Pumps were released without full testing being performed, including occlusion alarm testing.
2025-12-15
Open, Classified
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
2025-12-15
Open, Classified
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
2025-12-15
Open, Classified
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
2025-12-15
Open, Classified
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
2025-11-28
Open, Classified
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.
2025-11-21
Open, Classified
Emphasizing instructions for LVP duration programming located in the IFU.
2025-11-14
Open, Classified
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
2025-11-06
Open, Classified
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
2025-11-03
Open, Classified
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
2025-11-03
Open, Classified
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
2025-10-17
Open, Classified
If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.
2025-09-03
Open, Classified
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
2025-08-04
Open, Classified
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
2025-08-04
Open, Classified
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
2025-08-04
Open, Classified
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
2025-07-14
Open, Classified
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced.
Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that:
1) The door is fully open before loading the set.
2) The tubing is taut and loaded without slack in the pumping channel.
2025-07-14
Open, Classified
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
2025-07-11
Open, Classified
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
2025-07-08
Open, Classified
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
2025-07-08
Open, Classified
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
2025-05-12
Open, Classified
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
2025-05-07
Open, Classified
Unreleased software versions were installed on distributed devices without verification or validation.
2025-05-07
Open, Classified
Unreleased software versions were installed on distributed devices without verification or validation.
2025-05-07
Open, Classified
Unreleased software versions were installed on distributed devices without verification or validation.
2025-05-07
Open, Classified
Unreleased software versions were installed on distributed devices without verification or validation.
2025-04-24
Open, Classified
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
2025-04-22
Open, Classified
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
2025-04-22
Open, Classified
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
2025-04-10
Open, Classified
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
2025-04-10
Open, Classified
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
2025-03-03
Open, Classified
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.
2025-02-05
Open, Classified
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
2025-02-05
Open, Classified
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
2025-01-23
Open, Classified
Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.
2025-01-10
Open, Classified
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies:
1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more.
2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
2025-01-02
Open, Classified
Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set
2024-12-06
Open, Classified
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
2024-11-19
Open, Classified
Devices were identified as released after repair without full testing being performed, which includes flow testing.
2024-11-19
Open, Classified
Devices were identified as released after repair without full testing being performed, which includes flow testing.
2024-10-22
Open, Classified
ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.
2024-10-18
Open, Classified
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
2024-10-02
Open, Classified
The door on the Spectrum IQ Infusion pump may not be able to fully close.
2024-09-30
Open, Classified
For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.
2024-09-13
Open, Classified
There is a defect in the air-in-line software algorithm.
2024-08-30
Open, Classified
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
2024-08-15
Open, Classified
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
2024-08-15
Open, Classified
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
2024-08-15
Open, Classified
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
2024-08-15
Open, Classified
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
2024-08-15
Open, Classified
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
2024-08-07
Open, Classified
Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.
2024-07-17
Open, Classified
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
2024-07-17
Open, Classified
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ infusion system is integrated with the hospital s EMR system.
2024-07-16
Open, Classified
Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery pack case. If this issue occurs, the battery pack charging circuit may become inoperable.
Adverse events by year
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Methodology & data provenance
For your PSUR appendixSearch protocol: FDA MAUDE adverse event reports, FDA device recalls, and FDA enforcement reports (openFDA datasets) were queried for product code FRN, reporting period 2024-07 to 2026-06 (prior comparison period 2022-07 to 2024-06).
Data coverage: adverse event data for these product codes extends through 2026-05. Source openFDA export dated 2026-06-30. Recall records with missing or implausible initiation dates (0 for these codes) are excluded from period counts.
Generated: 2026-07-05 18:44 UTC by BEUDAMED (beudamed.com/fda/psur-report). Dataset sizes: 25,039,198 adverse events, 58,607 recalls, 39,365 enforcement reports.
PSUR database searches, explained
Under the EU MDR, manufacturers must produce a Periodic Safety Update Report (PSUR) (Class IIa and above; a PMS report for Class I) on a defined schedule. A required part of that report is a survey of publicly available vigilance data — most importantly the FDA's MAUDE adverse event database and FDA recall records — covering both your own device and similar devices on the market (the "state of the art").
Doing this by hand means repeated MAUDE queries, manual export, deduplication, and trending — hours of work per report, repeated every reporting period. This tool runs the same search protocol in seconds and documents it: which datasets were queried, with which filters, when, and with what coverage — so the search is reproducible, which is exactly what a Notified Body auditor wants to see.
Event counts are grouped by the FDA's reported event type (death, injury, malfunction). Name-based device matching is clearly labeled as indicative: only you can confirm whether a specific MAUDE report concerns your device. Recall records with implausible dates are excluded and the exclusion is disclosed. All data is from the official openFDA datasets and refreshed approximately monthly.