FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3221599
·
Received July 3, 2013
Report
- Report Number
- 1314492-2013-00978
- Event Type
- Malfunction
- Date Received
- July 3, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 4, 2013
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. A SYSTEM ERROR 322 ALARM WAS CONFIRMED THROUGH REVIEW OF THE DEVICE'S HISTORY LOG, AS WELL AS REPRODUCED DURING THE EVAL. THE DEVICE WAS RUN FOR (B)(4) HRS BEFORE EXPERIENCING A SYSTEM ERROR 322 ALARM. THIS ERROR WAS CAUSED BY A FAILED COMPONENT ON THE INPUT/OUTPUT PRINTED CIRCUIT BOARD (I/O PCB). THE I/O PCB WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP WAS ALARMING CONSTANTLY FOR SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303514 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |