FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 2140526
·
Received June 15, 2011
Report
- Report Number
- 9616066-2011-00317
- Event Type
- Malfunction
- Date Received
- June 15, 2011
- Report Date
- May 17, 2011
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K931173
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALTHOUGH REQUESTED, THE IV SET HAS NOT BEEN RECEIVED FOR INVESTIGATION. A F/U REPORT WILL BE SUBMITTED ONCE THE IV SET HAS BEEN RECEIVED AND AN INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE SET DEVELOPED A SMALL HOLE AT ONE END OF THE LONG PLASTIC PIECE THAT HELPS GUIDE THE TUBING THROUGH THE ALARIS PUMP. THE SMALL HOLE RESULTED IN A CHEMO SPILL. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE ADMINISTRATION SET | FPA | CAREFUSION CORP. | 2260-0500 | 10116045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS PC UNIT, SERIAL # UNK| ALARIS PUMP MODULE, SERIAL # UNK |