FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3191188
·
Received June 14, 2013
Report
- Report Number
- 1314492-2013-00787
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 17, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- 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). BAXTER REC'D AND EVALUATED THE DEVICE. THE EVALUATION CONFIRMED THAT THE DEVICE ALARMED FOR AN UPSTREAM OCCLUSION WHEN NO OCCLUSION WAS PRESENT. THIS WAS CAUSED BY THE UPPER SENSOR READING TO BE BELOW SPECIFICATION. THE UPSTREAM PUSHER THICKNESS WAS INCREASED AND THE DEVICE PERFORMED AS EXPECTED. REVIEW OF THE DEVICE HISTORY LOG SHOWS MULTIPLE AIR-IN-LINE ALARMS, HOWEVER NONE COULD BE REPRODUCED DURING THE EVALUATION. FURTHERMORE, THE SPECTRUM OPERATORS MANUAL WARNS THE USER THAT WHEN THE DEVICE ALARMS FOR AIR-IN-LINE, AN UPSTREAM OCCLUSION MAY EXIST.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP ALARMS CONSTANTLY FOR AIR IN LINE. NO PT INJURY WAS REPORTED AND NO ADD'L INFO COULD BE OBTAINED FROM THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272332 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |