FDA Adverse Event
Malfunction
Summary report: N
SPECTRUM INFUSION PUMP
MDR report key: 3062548
·
Received March 18, 2013
Report
- Report Number
- 1314492-2013-00260
- Event Type
- Malfunction
- Date Received
- March 18, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 18, 2013
- Manufacturer
- BAXTER HEALTHCARE CORPORATION
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS RECEIVED AND EVALUATED BY BAXTER. THE EVALUATION WAS UNABLE TO CONFIRM THAT THE PUMP WOULD NOT ALARM FOR AN OCCLUSION WHEN AN OCCLUSION WAS PRESENT. REVIEW OF THE DEVICE HISTORY LOG SHOWS THAT THE PUMP ALARMED FOR AN OCCLUSION MULTIPLE TIMES. UPSTREAM OCCLUSION AND DOWNSTREAM OCCLUSION TESTS WERE PERFORMED PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE WITH THE UNIT PASSING. ADDITIONALLY A FLOW RATE TEST WAS PERFORMED WITH THE DEVICE IN QUESTION, PER THE SPECTRUM PREVENTIVE MAINTENANCE PROCEDURE AND FOUND TO DELIVER WITHIN SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP DID NOT ALARM FOR AN OCCLUSION WHEN AN OCCLUSION WAS PRESENT (MEDICATION, PROGRAMMED AMOUNT AND DELIVERY RATE UNKNOWN).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 111637 | SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | BAXTER HEALTHCARE CORPORATION | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |