FDA Adverse Event
Malfunction
Summary report: N
INTERMATE
MDR report key: 3232918
·
Received July 18, 2013
Report
- Report Number
- 1416980-2013-18823
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Report Date
- June 24, 2013
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- FRN
- PMA / PMN Number
- K910425
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED 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. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A SUPPLEMENTAL MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEAK WAS OBSERVED IN A CE INTERMATE "CONTAINER." THE DEVICE WAS FILLED WITH CANCIDAS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 333956 | INTERMATE | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - IRVINE | 12D005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |