FDA Adverse Event
Malfunction
Summary report: N
AMBIT PUMP CASSETTE
MDR report key: 845061
·
Received February 28, 2007
Report
- Report Number
- 1722214-2007-00005
- Event Type
- Malfunction
- Date Received
- February 28, 2007
- Report Date
- March 23, 2006
- Manufacturer
- SORENSON MEDICAL, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IN 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 CHEMOTHERAPY DRUGS. SINCE THERE IS THE POTENTIAL FOR SERIOUS SIDE EFFECTS FROM THE EXPOSURE OF SOME CHEMOTHERAPY DRUG AGENTS TO UNPROTECTED SKIN, IT WAS THE OPINION OF OUR CLINICAL REVIEW BOARD TO IDENTIFY A CASSETTE LEAKAGE WHERE CHEMOTHERAPY DRUGS WERE INVOLVED AS AN MDR-REPORTABLE INCIDENT.
Description of Event or Problem · 1
A DISTRIBUTOR REPORTED A CASSETTE LEAKED WITH CHEMOTHERAPY. 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 | 511027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |