FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3935368
·
Received February 3, 2014
Report
- Report Number
- 1314492-2014-05670
- Event Type
- Malfunction
- Date Received
- February 3, 2014
- Manufacturer
- BAXTER HLTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE REPORTED SYSTEM ERROR 322 WAS REPRODUCED AND CONFIRMED THROUGH EVAL. PHYSICAL INSPECTION FOUND THAT THE UPPER LATCH SWITCH BRACKET SCREWS WERE LOOSE ALLOWING THE UPPER LATCH SWITCH TO MOVE IN AND OUT FROM THE UPPER DOOR LATCH. THE LOOSE SCREWS WILL TRIGGER AN INTERMITTENT OPEN/CLOSED SWITCH CONNECTION CAUSING THE REPORTED SYMPTOM. THE UPPER AUXILIARY WAS REPLACED. SYS 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 ALARMED SYSTEM ERROR 322. IT WAS ALSO REPORTED THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71667 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HLTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |