FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3344912
·
Received August 29, 2013
Report
- Report Number
- 1314492-2013-05642
- Event Type
- Malfunction
- Date Received
- August 29, 2013
- Date of Event
- July 1, 2013
- Report Date
- July 31, 2013
- Manufacturer
- BAXTER HEALTHCARE CORP
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
MFR REF NO: (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THIS COMPLAINT WAS OPENED DURING THE INVESTIGATION OF COMPLAINT (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 PROCESSOR OCB AND ULTRASONIC SENSOR WERE REPLACED.
Description of Event or Problem · 1
DURING THE EVAL OF A RETURNED SPECTRUM INFUSION PUMP, 8 OCCURRENCES OF "UPSTREAM 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 |
|---|---|---|---|---|---|---|---|
| 427505 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |