FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3253613
·
Received July 15, 2013
Report
- Report Number
- 1314492-2013-01197
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Date of Event
- June 1, 2013
- Report Date
- June 20, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 REPORTED "UPSTREAM OCCLUSION" 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 ULTRASONIC SENSOR WAS REPLACED.
Description of Event or Problem · 1
DURING THE EVALUATION OF A RETURNED SPECTRUM INFUSION PUMP, 40 OCCURRENCES OF "UPSTREAM OCCLUSION" ALARM WERE IDENTIFIED IN THE EVENT HISTORY LOG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED SINCE THESE ITEMS WERE FOUND DURING EVALUATION OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327496 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |