FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE IV ADMINISTRATION SET
MDR report key: 2123492
·
Received June 8, 2011
Report
- Report Number
- 9616066-2011-00308
- Event Type
- Malfunction
- Date Received
- June 8, 2011
- Report Date
- May 13, 2011
- Manufacturer
- CAREFUSION CORP
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS PENDING RECEIPT OF THE PRODUCT. A F/U REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
RECEIVED REPORT THAT A LEAK FROM TUBING WAS EXPERIENCED IN THE ICU. IT WAS LEAKING INTO THE PUMP. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. ATTEMPTS TO OBTAIN ADD'L CLINICAL INFO HAVE NOT BEEN SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE IV ADMINISTRATION SET | FPA | CAREFUSION CORP | 2420-0500 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PUMP MODULE, SERIAL # UNK| ALARIS PC UNIT, SERIAL # UNK |