ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-31569
- Event Type
- Malfunction
- Date Received
- July 11, 2024
- Date of Event
- June 18, 2024
- Report Date
- October 15, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810046
- PMA / PMN Number
- K211218
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
CORRECTION : UNIQUE IDENTIFIER (UDI) #. ADDITIONAL INFORMATION : MANUFACTURER NARRATIVE. INVESTIGATION SUMMARY: THE REPORTED COMPLAINT THAT THE PUMP MODULE HAD A CHANNEL ERROR (240.4150.0) WAS CONFIRMED THROUGH THE REVIEW OF THE LOGS; HOWEVER, IT WAS NOT REPLICATED TO THE DURING EXTENSIVE LABORATORY TESTING. A REVIEW OF THE SUSPECT PUMP MODULE ERROR LOG SHOWED ERROR CODE 240.4150.0 OCCURRED ON THE REPORTED DATE OF 18 JUNE 2024 AT 4:03 PM. THE LAST KNOWN INFUSION, PRIOR TO WHEN THE CHANNEL MALFUNCTION OCCURRED, BEGAN ON 18 JUNE 2024 AT 3:58 PM, WHEN THE SUSPECT PUMP MODULE (S/N: (B)(6)) WAS SELECTED AND PROGRAMMED AT A RATE OF 33.3ML/HR AND VTBI OF 100ML. A CHANNEL MALFUNCTION (240.4150.0) OCCURRED AT 4:03 PM. LABORATORY TESTING WAS UNABLE TO REPLICATE THE REPORTED CHANNEL MALFUNCTION 240.4150.0. IT WAS OBSERVED THAT THE SUSPECT PUMP MODULE¿S FSA SERIES BOTTLE-SIDE PRESSURE SENSOR¿S ZERO OFFSET VOLTAGE (0.9743.V) WAS WITHIN THE RANGE OF THE MANUFACTURER¿S ZERO OFFSET VOLTAGE OUTPUT (1.00 VOLTS +/- 0.154 VOLTS). ANALOG SENSOR TESTING OBSERVED THAT THE VOLTAGE INCREASED TO RAIL VOLTAGE (4.85V ¿ 5V) WHEN LIGHT PRESSURE WAS APPLIED TO THE SENSOR AND RETURNED TO THE ZERO OFFSET VOLTAGE WHEN THE PRESSURE WAS RELEASE. ADDITIONAL FUNCTIONAL TESTING FOR A CONTINUED INFUSION FOR A PERIOD OF FOUR DAYS UNABLE TO REPRODUCE THE ERROR. INSPECTION OF THE PRESSURE SENSOR OBSERVED THE SENSOR TO BE IN GOOD CONDITION WITH A JULIAN DATE CODE OF 01124 (11 JANUARY 2024) MAKING IT LESS THAN 1 YEAR OLD. THE ADMINISTRATION SET WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE, IT COULD NOT BE INSPECTED OR TESTED. PRESSURE SENSOR TIP SHEET CAUTIONS THE CLINICIAN TO AVOID PRESSURE SENSOR DAMAGE BY NOT APPLYING PRESSURE TO THE CENTER OF THE PRESSURE SENSORS. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE ROOT CAUSE OF THE REPORTED PUMP MODULE CHANNEL ERROR (240.4150.0) WAS NOT DETERMINED DURING EXTENSIVE LABORATORY TESTING.
A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.
OMIT : B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. CORRECTION : CORRECTION: UNIQUE DEVICE IDENTIFIER (UDI)# ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD. ADDITIONAL INFORMATION : DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER?, IMDRF ANNEX A, B, C, D, G CODES AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT.
IT WAS REPORTED THAT THIRTY (30) MINUTES INTO AN INFUSION OF PIPERACILLIN THE "CHANNEL MALFUNCTIONED AND ALARMED". CUSTOMER REPORTED THAT INFUSION HAD STOPPED. CLINICIAN REMOVED THE CHANNEL AND SWITCHED THE INFUSION TO ANOTHER CHANNEL. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT THIRTY (30) MINUTES INTO AN INFUSION OF PIPERACILLIN THE "CHANNEL MALFUNCTIONED AND ALARMED". CUSTOMER REPORTED THAT INFUSION HAD STOPPED. CLINICIAN REMOVED THE CHANNEL AND SWITCHED THE INFUSION TO ANOTHER CHANNEL. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT THIRTY (30) MINUTES INTO AN INFUSION OF PIPERACILLIN THE "CHANNEL MALFUNCTIONED AND ALARMED". CUSTOMER REPORTED THAT INFUSION HAD STOPPED. CLINICIAN REMOVED THE CHANNEL AND SWITCHED THE INFUSION TO ANOTHER CHANNEL. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271696 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015 |