FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3921582
·
Received February 6, 2014
Report
- Report Number
- 1314492-2014-06568
- Event Type
- Malfunction
- Date Received
- February 6, 2014
- Date of Event
- January 1, 2014
- Report Date
- January 10, 2014
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MFR REF NO: (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE REPORTED SYSTEM ERROR 105 WAS REPRODUCED AND CONFIRMED DURING EVAL. THIS ERROR MESSAGE HAS BEEN ATTRIBUTED TO A FAILED MOTOR (FLEX). THE MOTOR ASSEMBLY WAS REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A SPECTRUM PUMP HAD SYSTEM ERROR 105 ALARMS. ANY PT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76503 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |