FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3240938
·
Received July 17, 2013
Report
- Report Number
- 1314492-2013-01360
- Event Type
- Malfunction
- Date Received
- July 17, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 18, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. EVAL CONFIRMED THAT REPORTED SYMPTOM THROUGH THE DEVICE HISTORY LOG BUT WAS UNABLE TO REPRODUCE UNDER TEST. SYSTEM ERROR 322 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 UPPER AND LOWER AUX WILL BE REPLACED AS THEY ARE KNOWN TO CONTRIBUTE TO SYSTEM ERROR 322.
Description of Event or Problem · 1
IT WAS REPORTED THAT A DEVICE ALARMED FOR ERROR CODE 322. IT WAS ALSO REPORTED THAT THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332081 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |