FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3221970
·
Received July 5, 2013
Report
- Report Number
- 1314492-2013-01016
- Event Type
- Malfunction
- Date Received
- July 5, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 6, 2013
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. SYSTEM ERROR 322 ALARMS WERE CONFIRMED THROUGH REVIEW OF THE DEVICE HISTORY LOG. HOWEVER, IT COULD NOT BE REPRODUCED DURING THE EVALUATION. SYSTEM ERROR 322'S WILL OCCUR WHEN THE PUMP TRANSITIONS FROM THE DOOR OPEN STATE TO THE DOOR CLOSED/SET-LOADED STATE AND THE LOWER LINK SWITCH DOES NOT ACTIVATE. THE DEVICE WAS TESTED FOR 93+ HOURS AND NO MALFUNCTION COULD BE IDENTIFIED . THE UPPER AND LOWER AUXILIARY ASSEMBLIES WERE REPLACED BECAUSE THEY ARE KNOWN CONTRIBUTORS TO SYSTEM ERROR 322.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED FOR SYSTEM ERROR 322. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307103 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |