FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE
MDR report key: 2221949
·
Received August 17, 2011
Report
- Report Number
- 2016493-2011-00473
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 29, 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
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). LOG REVIEW PENDING. LOGS HAVE BEEN RECEIVED, BUT THE EVAL HAS NOT YET BEGUN. A F/U REPORT WILL BE SUBMITTED ONCE THE LOGS HAVE BEEN EVALUATED.
Description of Event or Problem · 1
CUSTOMER REPORTED AN OVER INFUSION OF CYTARABINE 6000MG IN 330ML FLUID (250ML BAG PLUS ADDITIONAL VOLUME FOR MEDICATION). THE CYTARABINE-HIGH DOSE WAS TO INFUSE OVER THREE HOURS. A LITTLE OVER AN HOUR LATER, THE DAY NURSE AND THE EVENING NURSE FOUND THE BAG COMPLETELY EMPTY. THEY BOTH LOOKED AT THE PUMP SETTINGS AND DETERMINED THAT THE SETTINGS WERE CORRECT. THERE WAS NO PT HARM. THE NURSE STATED THE PUMP WAS READING "LOW BATTERY" EVEN THOUGH IT WAS PLUGGED IN. 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 | 40 YR | ALARIS PC UNIT: SN (B)(4)| ALARIS ADMIN SET: MODEL UNK |