FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3597798
·
Received September 11, 2013
Report
- Report Number
- 1314492-2013-07013
- Event Type
- Malfunction
- Date Received
- September 11, 2013
- Date of Event
- August 1, 2013
- Report Date
- August 15, 2013
- Manufacturer
- BAXTER HEALTHCARE CORP.
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. UNIT WAS TESTED FOR 24 HOURS WITH NO OCCURRENCE OF EC (B)(4). REVIEW OF THE HISTORY LOG CONFIRMS THE EC 322 REPORTED SYMPTOM. EVALUATION WAS UNABLE TO DETERMINE THE CAUSE. EVALUATION OF KNOWN CONTRIBUTORS TO EC 322 HAS LED TO THE DETERMINATION THAT THE UPPER AND LOWER AUXILIARY WERE THE FAILING COMPONENTS AND WERE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP EXPERIENCED SYSTEM ERROR 322 - LINK SWITCH ERROR (LOW) ALARMS. THERE WAS ALSO NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 457513 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORP. | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |