ALARIS SYSTEM
Report
- Report Number
- 2016493-2022-198793
- Event Type
- Injury
- Date Received
- September 27, 2022
- Date of Event
- August 14, 2022
- Report Date
- October 12, 2022
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- PMA / PMN Number
- K133532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
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. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.
CORRECTION: UPON FURTHER REVIEW, IT WAS DETERMINED THAT THIS REPORT WAS SUBMITTED INADVERTENTLY AS THE EVENT HAS ALREADY BEEN PREVIOUSLY REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2022-193319.
RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA WHICH STATES, ¿AT 1642 A HEPARIN 25,000 UNIT/ 250 ML INFUSION BAG WAS STARTED ON AN ALARIS PUMP. AT 1707 THE PUMP ALARMED WITH AN AIR IN LINE ALERT. AT THAT TIME IT WAS IDENTIFIED THAT 250 ML HAD INFUSED OVER 25 MINUTES. SUBSEQUENT REVIEW OF THE PUMP PROGRAMMING SHOWED THAT THE PUMP WAS PROGRAMMED CORRECTLY AT A RATE OF 9.9 ML/HR BY THE NURSE. THE PATIENT WAS GIVEN PROTAMINE FOR HEPARIN REVERSAL. SUBSEQUENT APPROPRIATES WERE 40.7, 83.2, AND 64.9 AT 1824, 2221, AND 0054 RESPECTIVELY. THE PATIENT WAS MONITORED AND REVERSED WITH PROTAMINE APPROPRIATELY AND DID NOT HAVE AN ADVERSE REACTION TO THE HEPARIN INFUSION. OF NOTE THE THERAPEUTIC RANGE FOR THIS PATIENT WAS 45 - 70 SECONDS FOR THEM TO BE ANTICOAGULATED. FDA SAFETY REPORT ID # (B)(4)."
RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM FDA WHICH STATES, ¿AT 1642 A HEPARIN 25,000 UNIT/ 250 ML INFUSION BAG WAS STARTED ON AN ALARIS PUMP. AT 1707 THE PUMP ALARMED WITH AN AIR IN LINE ALERT. AT THAT TIME IT WAS IDENTIFIED THAT 250 ML HAD INFUSED OVER 25 MINUTES. SUBSEQUENT REVIEW OF THE PUMP PROGRAMMING SHOWED THAT THE PUMP WAS PROGRAMMED CORRECTLY AT A RATE OF 9.9 ML/HR BY THE NURSE. THE PATIENT WAS GIVEN PROTAMINE FOR HEPARIN REVERSAL. SUBSEQUENT APPROPRIATES WERE 40.7, 83.2, AND 64.9 AT 1824, 2221, AND 0054 RESPECTIVELY. THE PATIENT WAS MONITORED AND REVERSED WITH PROTAMINE APPROPRIATELY AND DID NOT HAVE AN ADVERSE REACTION TO THE HEPARIN INFUSION. OF NOTE THE THERAPEUTIC RANGE FOR THIS PATIENT WAS 45 - 70 SECONDS FOR THEM TO BE ANTICOAGULATED. FDA SAFETY REPORT ID # (B)(4)."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2258475 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | 8015 |