FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3221995
·
Received July 5, 2013
Report
- Report Number
- 1314492-2013-01039
- Event Type
- Malfunction
- Date Received
- July 5, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 12, 2013
- 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). DURING BAXTER'S EVALUATION OF THE DEVICE, IT WAS DISCOVERED THAT THERE WAS A DELAY IN KEYPAD RESPONSE. THE DELAY IN RESPONSE WAS APPROXIMATELY 3 SECONDS. THIS WAS CAUSED BY A FAILED PROCESSOR PRINTED CIRCUIT BOARD (PCB). THE PROCESSOR PCB WAS REPLACED.
Description of Event or Problem · 1
DURING BAXTER'S EVALUATION, A DEVICE WAS FOUND TO HAVE A KEYPAD ANOMALY. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307607 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |