FDA Adverse Event
Malfunction
Summary report: N
AMBIT PUMP CASSETTE
MDR report key: 843291
·
Received February 28, 2007
Report
- Report Number
- 1722214-2007-00011
- Event Type
- Malfunction
- Date Received
- February 28, 2007
- Report Date
- September 5, 2006
- Manufacturer
- SORENSON MEDICAL, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON FEBRUARY 23, 2007, A RETROSPECTIVE AUDIT OF COMPLAINT FILES WAS CONDUCTED FOR COMPLAINTS ASSOCIATED WITH LEAKING CASSETTES, WHERE THE DEVICE WAS BEING USED FOR THE ADMINISTRATION OF NON-CHEMOTHERAPY DRUGS.
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED A LEAKING CASSETTE. THE THERAPY WAS PAIN MANAGEMENT. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENT ASSOCIATED WITH THIS MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMBIT PUMP CASSETTE | AMBULATORY INFUSION PUMP CASSETTE | FRN | SORENSON MEDICAL, INC. | NA | 605025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |