FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 4291701
·
Received March 27, 2014
Report
- Report Number
- 1314492-2014-17750
- Event Type
- Malfunction
- Date Received
- March 27, 2014
- Date of Event
- January 1, 2014
- Report Date
- March 4, 2014
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 132475. THE IDENTIFIED "AIR-IN-LINE" 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 ULTRASONIC PUSHER WAS REPLACED.
Description of Event or Problem · 1
DURING EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, 67 OCCURRENCES OF "AIR-IN-LINE" ALARM WERE IDENTIFIED IN THE EVENT HISTORY LOG. ANY PT 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 |
|---|---|---|---|---|---|---|---|
| 182619 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP. | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |