FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3373550
·
Received September 20, 2013
Report
- Report Number
- 1314492-2013-08042
- Event Type
- Malfunction
- Date Received
- September 20, 2013
- Date of Event
- August 1, 2013
- Report Date
- August 23, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE REPORTED SYMPTOM "UNIT FAILED PREVENTATIVE MAINTENANCE FLOW RATE ACCURACY TEST" WAS CONFIRMED AND REPRODUCED. THE UNIT FAILED FLOW RATE TEST IAW THE PM PROCEDURE. IT WAS FOUND THROUGH EVALUATION THAT THE UPPER FINGER/VALVE, AND THE LOWER FINGER/VALVE WERE OUT OF SPEC. CAUSING THE UNDER INFUSION. AS A RESULT, THE VALVES WILL BE ADJUSTED AND CALIBRATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP FAILED A PREVENTATIVE MAINTENANCE FLOW RATE ACCURACY TEST. ANY PATIENT INVOLVEMENT, INJURY OR MEDIAL INTERVENTION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 474860 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |