FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3861727
·
Received January 13, 2014
Report
- Report Number
- 1314492-2014-02605
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- November 1, 2013
- Report Date
- December 17, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- NOT APPLICABLE
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 IDENTIFIED "AIR-IN-LINE" ALARMS WERE CONFIRMED THROUGH THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS UNDETERMINED. IF ANY ADD'L INFO IS REC'D, A F/U WILL BE SENT. THE ULTRASONIC SENSOR AND ULTRASONIC WERE REPLACED.
Description of Event or Problem · 1
DURING THE EVAL OF A RETURNED SPECTRUM INFUSION PUMP, 170 OCCURRENCES OF "AIR-IN-LINE" ALARMS WERE IDENTIFIED IN THE EVENT HISTORY LOG. ANY PT INJURY OR MEDICAL INTERVENTION IS UNK SINCE THESE ITEMS WERE FOUND DURING EVAL OF THE DEVICE. NO ADD'L INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31544 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |