FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3760602
·
Received December 19, 2013
Report
- Report Number
- 1314492-2013-22504
- Event Type
- Malfunction
- Date Received
- December 19, 2013
- Date of Event
- October 1, 2013
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THIS COMPLAINT WAS OPENED DURING THE INVESTIGATION OF COMPLAINT (B)(4). THE "DOOR JAMMED" ALARMS WERE CONFIRMED THROUGH AN EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP WILL BE SENT. THE MACHINED DOOR, DOOR LATCH HOOK, AND INPUT/OUTPUT PRINTED CIRCUIT BOARD WERE REPLACED.
Description of Event or Problem · 1
DURING THE EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, 2 OCCURRENCES OF "DOOR JAMMED" ALARMS WERE IDENTIFIED IN THE EVENT HISTORY LOG. ANY PT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNK SINCE THESE ITEMS WERE FOUND DURING EVALUATION OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 666402 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |