FDA Adverse Event
Malfunction
Summary report: N
INFUSOR
MDR report key: 4093697
·
Received September 16, 2014
Report
- Report Number
- 1416980-2014-31571
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Report Date
- August 22, 2014
- Manufacturer
- BAXTER HEALTHCARE - IRVINE
- Product Code
- FRN
- PMA / PMN Number
- K853881
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN INFUSOR PATIENT CONTROL MODULE (PCM) WATCH HAD A LOOSE AND PARTIALLY DETACHED BUTTON. THE REPORTER STATED THAT AFTER REMOVING THE SECURING CLIP, THE SPRING TENSION UNDER THE BUTTON CAUSED THE BACK-PLATE TO PARTIALLY DETACH FROM THE BODY AND NOT FULLY OCCLUDE THE FLUID LINE. THIS WAS FOUND BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 60 OF 91.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572952 | INFUSOR | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - IRVINE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |