FDA Adverse Event
Malfunction
Summary report: N
KANGAROO
MDR report key: 2250882
·
Received August 28, 2011
Report
- Report Number
- 2250882
- Event Type
- Malfunction
- Date Received
- August 28, 2011
- Date of Event
- August 6, 2011
- Report Date
- August 28, 2011
- Manufacturer
- KENDALL (COVIDIEN)
- Product Code
- LZH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FIRST NEW KANGAROO PUMP (B)(6) HAD BEEN BEEPING HOLD ERROR ON AND OFF. ALSO IT WOULD NOT LET USER PRIME PUMP. HAD TO TURN PUMP ON AND OFF A FEW TIMES TO PRIME BAG. FINALLY WE SWITCHED TO A NEW KANGAROO PUMP ((B)(6), STILL ONE OF OUR NEW PUMPS). PUMP SWITCHED ON ITS OWN FROM RUNNING AT 32CC/HR TO RUNNING 260CC/HR. FOUND OUT ABOUT THIS B/C BAG WAS EMPTY AND PUMP BEEPING. LOOKING BACK AT PUMP IT APPEARS PATIENT RECEIVED 63ML BOLUS. NURSE HELD FEEDS X1 HOUR. NOTIFIED MD OF WHAT HAD HAPPENED. PATIENT TOLERATED FEEDING WELL WITH NO EMESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KANGAROO | INFUSION PUMP, ENTERAL | LZH | KENDALL (COVIDIEN) | EPUMP | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO |