FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3925022
·
Received February 5, 2014
Report
- Report Number
- 1314492-2014-06274
- Event Type
- Malfunction
- Date Received
- February 5, 2014
- Date of Event
- January 3, 2014
- Report Date
- January 9, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED AND REPRODUCED THE REPORTED SYMPTOM SYSTEM ERROR 322 CAUSED BY LOOSE UPPER LATCH SWITCH BRACKET SCREWS. THE UPPER AUXILIARY ASSEMBLY WAS REPLACED. 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP ALARMED SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75927 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |