FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE
MDR report key: 2223033
·
Received August 17, 2011
Report
- Report Number
- 2016493-2011-00474
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- May 2, 2011
- Report Date
- August 1, 2011
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FRN
- PMA / PMN Number
- K950419
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
MFR'S REPORT DATE: (B)(4) 2011. (B)(4). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.
Description of Event or Problem · 1
CUSTOMER REPORTED AN OVER INFUSION OF INTRALIPIDS. INTRALIPIDS WERE BEING INFUSED AT 1.5ML/HOUR. EACH HOUR, NURSE NOTED CORRECT INFUSION AMOUNT UNTIL 11:00 AM WHEN SHE NOTED 8.8MLS HAD GONE OVER THAT HOUR DESPITE THE FACT THAT NO ONE HAD ADJUSTED THE PUMP RATE. THE PUMP RATE ON THE DISPLAY HAD INCREASED FROM 1.5ML/HOUR TO 7MLS/HOUR. THERE WAS NO REPORT OF PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE | FRN | CAREFUSION CORP. | 8100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 DA |