FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3934557
·
Received February 4, 2014
Report
- Report Number
- 1314492-2014-06150
- Event Type
- Malfunction
- Date Received
- February 4, 2014
- Date of Event
- December 1, 2013
- Report Date
- January 8, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THIS COMPLAINT WAS OPENED DURING THE INVESTIGATION OF (B)(4). THE IDENTIFIED "SYSTEM ERROR 105" ALARMS WERE CONFIRMED THROUGH THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADDITIONAL INFO IS RECEIVED A FOLLOW UP WILL BE SENT. THE ACETAL GEAR AND INPUT/OUTPUT PRINTED CIRCUIT BOARD WERE REPLACED.
Description of Event or Problem · 1
DURING THE EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, 3 OCCURRENCE OF "SYSTEM ERROR 105" 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 |
|---|---|---|---|---|---|---|---|
| 72080 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |