FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3240910
·
Received July 17, 2013
Report
- Report Number
- 1314492-2013-01355
- 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
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVAL WAS PERFORMED. THE EVAL FOUND THE UPPER LATCH SWITCH BRACKET SCREWS TO BE LOOSE ALLOWING THE UPPER LATCH SWITCH TO MOVE IN AND OUT FROM THE UPPER DOOR LATCH. THE LOOSE NYLON SCREWS WILL TRIGGER AN INTERMITTENT OPEN/CLOSED SWITCH CONNECTION CAUSING THE EC 322. THE UPPER AUXILIARY ASSEMBLY WILL BE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP HAS A SYSTEM ERROR 322. THE CUSTOMER STATED THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332929 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |