FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE SET
MDR report key: 4131318
·
Received September 19, 2014
Report
- Report Number
- 4131318
- Event Type
- Malfunction
- Date Received
- September 19, 2014
- Date of Event
- May 7, 2014
- Report Date
- September 19, 2014
- Manufacturer
- CAREFUSION
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
FAULTY TUBING. PRIMARY TUBING WAS PRIMED WITH MICRO-FILTER ADDED TO THE END OF IT. ATTACHED TO PATIENT AND BEGAN INFUSION. A COUPLE MINUTES LATER THERE WAS A LARGE AMOUNT OF AIR-IN-LINE, FOLLOWED BY FLUID. EITHER FAULTY PUMP OR FAULTY TUBING TO HAVE PULLED A LARGE SECTION OF AIR INTO THE TUBING THAT WAS PRIMED. ALSO, MICRO-FILTER WOULD NOT DISCONNECT FROM TUBING. ATTEMPTED DISCONNECTING FILTER TUBING FROM PRIMARY LINE USING 2 HEMOSTATS, UNSUCCESSFUL. HAVE TO REORDER MEDICATION AND PATIENT HAS A DELAYED ADMINISTRATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583127 | ALARIS PUMP MODULE SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CAREFUSION | UNK | UNK | |
| 583128 | * | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CAREFUSION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |