FDA Adverse Event
Malfunction
Summary report: N
INFUSO.R.
MDR report key: 2895504
·
Received January 3, 2013
Report
- Report Number
- 1416980-2013-00192
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Date of Event
- December 11, 2012
- Report Date
- December 11, 2012
- Manufacturer
- BAXTER HEALTHCARE - SINGAPORE
- Product Code
- FRN
- PMA / PMN Number
- K883577
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED. THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE CAUSE WAS DETERMINED TO BE A MISSING MOUNTING PLATE SMALL SCREW. NO REPAIRS HAVE BEEN PERFORMED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.
Description of Event or Problem · 1
DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A INFUSOR PUMP WAS FOUND TO HAVE A MISSING MOUNTING PLATE SMALL SCREW. THIS WAS NOT REPORTED BY THE CUSTOMER. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2418 | INFUSO.R. | PUMP, INFUSION | FRN | BAXTER HEALTHCARE - SINGAPORE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |