FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3853379
·
Received January 23, 2014
Report
- Report Number
- 1314492-2014-04229
- Event Type
- Malfunction
- Date Received
- January 23, 2014
- Date of Event
- December 1, 2013
- Report Date
- December 30, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 "DOWNSTREAM OCCLUSION" ALARMS WERE CONFIRMED THROUGH THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADD'L INFO IS RECEIVED, A F/U WILL BE SENT. THE FORCE SENSOR GASKET, FORCE SENSOR PUSHER, DOWNSTREAM TUBING GUIDE, AND INPUT/OUTPUT PRINTED CIRCUIT BOARD WERE REPLACED.
Description of Event or Problem · 1
DURING THE EVAL OF A RETURNED SPECTRUM INFUSION PUMP, 73 OCCURRENCES OF "DOWNSTREAM OCCLUSION" ALARMS WERE IDENTIFIED IN THE EVENT HISTORY LOG. ANY PT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNK SINCE THESE ITEMS WERE FOUND DURING EVAL OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55178 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |