FDA Adverse Event
Malfunction
Summary report: N
ON-Q PUMP WITH ONDEMAND BOLUS BUTTON
MDR report key: 4189835
·
Received October 15, 2014
Report
- Report Number
- MW5038669
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- October 14, 2014
- Report Date
- October 15, 2014
- Manufacturer
- I-FLOW
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
ON-Q PUMP WITH ROPIVACAINE 0.2% HAD AN ON DEMAND BOLUS BUTTON MALFUNCTION (DID NOT LATCH INTO PLACE) AND DID NOT DELIVER THE 5 ML DOSE OVER 30 MINUTES. DESPITE THE EFFORTS OF PHARMACY AND NURSING STAFF TO CORRECT AND TROUBLESHOOT, THE DEVICE WOULD NOT WORK PROPERLY. A SECOND ON-Q PUMP WITHIN THE SAME LOT NUMBER WAS ATTEMPTED AND RESULTED IN THE SAME BOLUS BUTTON MALFUNCTION. A THIRD ON-Q PUMP FROM A DIFFERENT LOT NUMBER WAS ATTEMPTED AND WORKED PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652420 | ON-Q PUMP WITH ONDEMAND BOLUS BUTTON | ON-Q PUMP WITH ONDEMAND BOLUS BUTTON | MEB | I-FLOW | CB006 | 0200991709 | |
| 652421 | ON-Q PUMP WITH ONDEMAND BOLUS BUTTON | ON-Q PUMP WITH ONDEMAND BOLUS BUTTON | MEB | I-FLOW | CB006 | 0200991709 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |