FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 1972661
·
Received January 20, 2011
Report
- Report Number
- 9616066-2011-00017
- Event Type
- Malfunction
- Date Received
- January 20, 2011
- Date of Event
- December 1, 2010
- Report Date
- December 22, 2010
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
MFR'S REPORT DATE: 01/20/2011. (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. SINCE THE PRODUCT WAS DISCARDED, WE WERE UNABLE TO PERFORM AN INVESTIGATION, THE ROOT CAUSE OF CUSTOMER'S EXPERIENCE IS UNK.
Description of Event or Problem · 1
CUSTOMER REPORTED, FLUID LEAKING FROM A PRIMARY ADMINISTRATION SET, MODEL AND LOT NUMBER UNK. ALTHOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ALARIS SYSTEM PUMP MODULE, SERIAL NUMBER UNKNOWN| ALARIS SYSTEM PC UNIT, SERIAL NUMBER UNKNOWN |