FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3792451
·
Received December 31, 2013
Report
- Report Number
- 1314492-2013-23932
- Event Type
- Malfunction
- Date Received
- December 31, 2013
- Date of Event
- December 1, 2013
- Report Date
- December 4, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS EVALUATED BY BAXTER. THE REPORTED SYMPTOM WAS CONFIRMED AND REPRODUCED. THE UNIT WAS RECEIVED INOPERABLE DUE TO CONSTANT "DOOR NOT FULLY LATCHED" MESSAGES CORRESPONDING WITH THE REPORTED SYMPTOM CAUSED BY A LOOSE LINK SCREW (UPPER). THE SCREW WAS ADJUSTED DURING EVALUATION WITH THE DOOR PERFORMING AS EXPECTED. THE SCREWS WERE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP DISPLAYED DOOR NOT LATCHED MESSAGES. IT WAS DETERMINED THAT THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 683276 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |