FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3925055
·
Received February 5, 2014
Report
- Report Number
- 1314492-2014-06287
- Event Type
- Malfunction
- Date Received
- February 5, 2014
- Date of Event
- January 1, 2014
- Report Date
- January 9, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE REPORTED SYSTEM ERROR 105 WAS CONFIRMED THROUGH REVIEW OF THE EVENT HISTORY LOG. ALSO, PHYSICAL INSPECTION FOUND SEVERED MOTOR MOUNT SCREWS WHICH IS KNOWN TO CONTRIBUTE TO THE REPORTED SYMPTOM. THE MOTOR AND MOTOR MOUNT SCREWS WERE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP HAD A SYSTEM ERROR 105. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76069 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |