FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 4305070
·
Received April 7, 2014
Report
- Report Number
- 1314492-2014-20516
- Event Type
- Malfunction
- Date Received
- April 7, 2014
- Date of Event
- February 1, 2014
- Report Date
- March 17, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 COMPLAINT 140734. THE IDENTIFIED "SYSTEM ERROR 105" ALARMS WERE CONFIRMED THROUGH THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP WILL BE SENT. THE ACETAL GEAR WAS REPLACED.
Description of Event or Problem · 1
DURING THE EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, 21 OCCURRENCES OF "SYSTEM ERROR 105" ALARMS WERE IDENTIFIED IN THE EVENT HISTORY LOG. ANY PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNKNOWN SINCE THESE ITEMS WERE FOUND DURING EVALUATION OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210124 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |