FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3934354
·
Received February 4, 2014
Report
- Report Number
- 1314492-2014-06217
- Event Type
- Malfunction
- Date Received
- February 4, 2014
- Date of Event
- January 1, 2014
- Report Date
- January 8, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REF NO: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE EVALUATION CONFIRMED AND REPRODUCED THE SYSTEM ERROR 105 CAUSED BY SEVERED MOTOR MOUNT SCREWS. THE MOTOR AND MOTOR MOUNT SCREWS WERE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A DEVICE IS ALARMING SYSTEM ERROR 105. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71808 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |