FDA Adverse Event
Malfunction
Summary report: N
INFUSOR
MDR report key: 3882231
·
Received June 18, 2014
Report
- Report Number
- 1416980-2014-19433
- Event Type
- Malfunction
- Date Received
- June 18, 2014
- Report Date
- May 26, 2014
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- MEB
- PMA / PMN Number
- K071222
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS MANUFACTURED MAY 8, 2013 ¿ MAY 9, 2013. A BATCH REVIEW WAS COMPLETED AND THERE WERE NO ISSUES FOUND IN THE LOT 13E022 BATCH RECORDS OR PRIOR AND SUBSEQUENT LOTS THAT COULD BE RELATED TO THE REPORTED PROBLEM. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A LARGE VOLUME INFUSOR LEAKED BETWEEN THE COIL CAP AND THE BLADDER. THIS OCCURRED DURING FILLING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358684 | INFUSOR | PUMP, INFUSION, ELASTOMERIC | MEB | BAXTER HEALTHCARE - IRVINE | 13E022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |