FDA Adverse Event
Malfunction
Summary report: N
AMBIT PUMP CASSETTE
MDR report key: 843294
·
Received February 28, 2007
Report
- Report Number
- 1722214-2007-00010
- Event Type
- Malfunction
- Date Received
- February 28, 2007
- Report Date
- February 17, 2006
- Manufacturer
- SORENSON MEDICAL, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON FEBRUARY 22, 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 THE PATIENT WAS ALERTED TO BLOOD THAT HAD BACKED UP THE TUBING AND LEAKED FROM THE PUMP. THE THERAPY WAS HYDRATION. 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 | 511029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |