FDA Adverse Event
Malfunction
Summary report: N
FOLFUSOR
MDR report key: 3840819
·
Received May 30, 2014
Report
- Report Number
- 1416980-2014-17409
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Report Date
- May 7, 2014
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SMALL VOLUME FOLFUSOR WAS ¿LEAKING AT THE FILLING PORT.¿ THE DEVICE HAD BEEN FILLED WITH HEPARIN AND SODIUM CHLORIDE SOLUTION. THIS OCCURRED AFTER FILLING, BUT BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 318477 | FOLFUSOR | PUMP, INFUSION, ELASTOMERIC | MEB | BAXTER HEALTHCARE - IRVINE | 12N034 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |