ALARIS PUMP MODULE
Report
- Report Number
- 2016493-2020-00261
- Event Type
- Malfunction
- Date Received
- February 24, 2020
- Date of Event
- January 29, 2020
- Report Date
- February 6, 2020
- Manufacturer
- CAREFUSION
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
SUPPLEMENTAL MDR TO CORRECT PATIENT WEIGHT UNITS (LBS) -ADDITIONAL INFORMATION ADDED TO: A4 ADDITIONAL PATIENT INFORMATION: DIAGNOSIS: NSTEMI;PMH: AS PER MEDICINE PROGRESS NOTE DATED 30JAN2019: PMHX OF CAD S/P PCI (STENTS LAD, CX, RCA), CHRONIC SYSTOLIC AND DIASTOLIC HEART FAILURE (EF 25%) S/P SINGLE CHAMBER ICD PLACEMENT, PAROXYSMAL AFIB ON WARFARIN, PUD W/ RECENT ADMISSION FOR GIB, VENOUS STASIS, T2DM, HTN, AND GERD WHO WAS ADMITTED FOR NSTEMI.
ADDITIONAL INFORMATION ADDED TO: A1,D4,D11 THE SOLE SUSPECT DEVICE IS BELIEVED TO BE 8100 LVP S/N (B)(6) . THOUGH THE CUSTOMER¿S COMPLAINT OF OVER INFUSION WAS NOT CONFIRMED IN THE LOGS NOR REPRODUCED DURING TESTING, IT IS BELIEVED THAT THE BROKEN UPPER HINGE POST OF THE PLATEN CONTRIBUTED TO THE UNREGULATED FLOW EVENT. ¿ ON THE REPORTED EVENT DATE (B)(6)2020 , THE SUSPECT DEVICE WAS PROGRAMMED FOR AN INFUSION OF 200 ML OF HEPARIN TO INFUSE AT A RATE OF 10 ML/HR. THE DEVICE ALARMED FOR AIR IN LINE AFTER BARELY TWO (2) HOURS OF INFUSING. THE INFUSION WAS RESTORED BUT ALARMED FOR AIR IN LINE ALMOST IMMEDIATELY. ¿ TESTING SHOWED THE DEVICE WAS DELIVERING IV FLUIDS WITHIN SPECIFICATION. ¿ INSPECTION OF THE SUSPECT DEVICE FOUND A BROKEN UPPER HINGE POST ON THE PLATEN. ¿ INSPECTION OF THE SUSPECT DEVICE FOUND NO ANOMALIES WITH THE PUMPING MECHANISM. THE ROOT CAUSE OF THE REPORTED OVER INFUSION COULD NOT BE DEFINITIVELY DETERMINED. IT IS BELIEVED THAT THE BROKEN UPPER HINGE POST OF THE PLATEN CONTRIBUTED TO THE UNREGULATED FLOW EVENT.
IT WAS REPORTED FROM 4 EAST THAT AT 1730 THE PATIENT WAS TRANSFERRED TO 2 WEST WITH AN INFUSION OF HEPARIN/250ML INFUSING AT 10ML/HR. ONCE TRANSFERRED, THE PUMP SETTINGS WERE VERIFIED BY THE OFF-GOING AND RECEIVING NURSE TO BE CORRECT. AT APPROXIMATELY 1930, THE 2 WEST NURSE NOTED THAT THE HEPARIN BAG WAS COMPLETED SOONER THAN EXPECTED. THE 2 WEST NURSE CALLED THE 4 EAST NURSE TO VALIDATE THAT THE HEPARIN BAG WAS FULL WHEN THE INFUSION WAS INITIATED AT 1630, IN WHICH THE 4 EAST NURSE STATED THAT IT WAS FULL. THE NURSE NOTIFIED THE MD AND RECEIVED ORDERS FOR LAB WORK AND TO MONITOR FOR BLEEDING. THERE WERE NO ADVERSE EFFECT CAUSE TO THE PATIENT FROM THE EVENT.
IT WAS REPORTED FROM (B)(4) EAST THAT AT 1730 THE PATIENT WAS TRANSFERRED TO (B)(4) WEST WITH AN INFUSION OF HEPARIN/250ML INFUSING AT 10ML/HR. ONCE TRANSFERRED, THE PUMP SETTINGS WERE VERIFIED BY THE OFF-GOING AND RECEIVING NURSE TO BE CORRECT. AT APPROXIMATELY (B)(4) , THE (B)(4) WEST NURSE NOTED THAT THE HEPARIN BAG WAS COMPLETED SOONER THAN EXPECTED. THE (B)(4) WEST NURSE CALLED THE (B)(4) EAST NURSE TO VALIDATE THAT THE HEPARIN BAG WAS FULL WHEN THE INFUSION WAS INITIATED AT 1630, IN WHICH THE (B)(4) EAST NURSE STATED THAT IT WAS FULL. THE NURSE NOTIFIED THE MD AND RECEIVED ORDERS FOR LAB WORK AND TO MONITOR FOR BLEEDING. THERE WERE NO ADVERSE EFFECT CAUSE TO THE PATIENT FROM THE EVENT.
THE AFFECTED DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.
IT WAS REPORTED THAT A EVENT OCCURRED IN (B)(6) WERE A PUMP EVENT WITH A OVER INFUSION OCCURRED. THE PATIENT DID NOT HAVE ANY ADVERSE EVENTS. THERE WAS NO BLEEDING AND NO ADDITIONAL INTERVENTIONS WERE NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 208541 | ALARIS PUMP MODULE | PUMP, INFUSION | FRN | CAREFUSION | 8100ADXEN933 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | 8015,PRI TUBING, THERAPY DATE (B)(6) 2020| 8100 |