FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3220656
·
Received June 25, 2013
Report
- Report Number
- 1314492-2013-00850
- Event Type
- Malfunction
- Date Received
- June 25, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 3, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE IN QUESTION. A SYSTEM ERROR 322 WAS CONFIRMED AND REPRODUCED DURING THE EVALUATION. THE ALARM WAS CAUSED BY A FAILED UPPER LATCH SWITCH WHICH 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 FOR A SYSTEM ERROR 322 DURING AN INFUSION (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN). IT IS UNKNOWN WHICH CARE AREA THIS ALARM OCCURRED IN, AND THERE WAS NO REPORTED PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288585 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |