FDA Adverse Event
Malfunction
Summary report: N
ON-Q
MDR report key: 1929488
·
Received December 10, 2010
Report
- Report Number
- 1929488
- Event Type
- Malfunction
- Date Received
- December 10, 2010
- Date of Event
- November 30, 2010
- Report Date
- December 10, 2010
- Manufacturer
- I-FLOW CORPORATION
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE PAIN SERVICE RN CALLED THE PATIENT AT HOME TO FOLLOW UP PAIN CONTROL WITH AN I-FLOW ON-Q PAIN PUMP. PATIENT STATED IT LEAKED SO BADLY THAT AFTER HE'D GONE THROUGH 7 SHIRTS, HE STOPPED USING THE PUMP. PATIENT RETURNED PUMP TO HOSPITAL, AND WE WILL RETURN TO I-FLOW CORPORATION TO INVESTIGATE. THIS WAS A 600ML PUMP, LOT #082294, MODEL #CB6004. IT WAS FILLED TO 700ML, WHICH THE MANUFACTURER SAYS IS OKAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ON-Q | PUMP, INFUSION, ELASTOMERIC | MEB | I-FLOW CORPORATION | CB6004 | 082294 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |