FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3935111
·
Received February 3, 2014
Report
- Report Number
- 1314492-2014-05600
- Event Type
- Malfunction
- Date Received
- February 3, 2014
- Date of Event
- January 1, 2014
- Report Date
- January 7, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REF NO.: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED AND REPRODUCED REPORTED SYMPTOM SYSTEM ERROR 322 CAUSED BY LOOSE LOWER LATCH SWITCH BRACKET SCREWS. AS A RESULT, THE LOWER 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 SPECTRUM PUMP WAS ALARMED FOR SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69888 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |