FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3032172
·
Received March 7, 2013
Report
- Report Number
- 1314492-2013-00209
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- January 25, 2013
- Report Date
- February 7, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE EVALUATION CONFIRMED THAT WHEN PRESSURE IS APPLIED TO THE PUMP DOOR AREA THE DEVICE WILL POWER ON. IT WAS ALSO OBSERVED THAT THE PUMP WILL NOT POWER OFF. FURTHER EVALUATION DETERMINED THAT THIS WAS CAUSED BY A FAILED UPPER LATCH SWITCH. THE FAILED UPPER LATCH SWITCH WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WOULD POWER ON WHEN THE DOOR WAS PRESSED. THE CUSTOMER ALSO STATED THAT THE PUMP WOULD NOT POWER OFF AND THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98345 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |