FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3221933
·
Received July 5, 2013
Report
- Report Number
- 1314492-2013-01008
- Event Type
- Malfunction
- Date Received
- July 5, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 6, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION AND THEREFORE AN EVALUATION COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP, DELIVERED FROM THE "ORTHO" UNIT, WILL NOT STOP ALARMING. WHEN THE CUSTOMER WAS INSTRUCTED TO CHECK THE PUMP'S EVENT HISTORY LOG, HE FOUND SYSTEM ERROR 322 ALARMS ON (B)(6) 2013. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY AS A RESULT OF THESE ALARMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307124 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |