FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 3110167
·
Received May 13, 2013
Report
- Report Number
- 1416980-2013-12216
- Event Type
- Malfunction
- Date Received
- May 13, 2013
- Report Date
- April 18, 2013
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- FRN
- PMA / PMN Number
- K910425
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. THE RUPTURED RESERVOIR WAS CONFIRMED DURING VISUAL. HOWEVER, A CAUSE COULD NOT BE DETERMINED DURING MICROSCOPIC INSPECTION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RESERVOIR OF A SMALL VOLUME INTERMATE HAD RUPTURED. THIS OCCURRED WHILE THE DEVICE WAS BEING FILLED WITH NACL. THIS MALFUNCTION RESULTED IN 88ML OF SOLUTION SPILLING INTO THE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210351 | ACCESS | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - IRVINE | 13A052 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |