FDA Adverse Event
Malfunction
Summary report: N
CARDINAL HEALTH - ALARIS PRODUCTS
MDR report key: 1174105
·
Received September 22, 2008
Report
- Report Number
- MW5008402
- Event Type
- Malfunction
- Date Received
- September 22, 2008
- Date of Event
- August 13, 2008
- Report Date
- September 22, 2008
- Manufacturer
- CARDINAL HEALTH ALARIS PRODUCTS
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NE, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
FOLLOW UP TO REPORT FROM 2008: IN AN ATTEMPT TO RECREATE EVENTS FROM THE DAY OF EVENT, TWO ALARIS POINT OF CARE UNITS WERE PLUGGED INTO THE SAME OUTLET IN THE SAME ROOM AS DURING THE FAILURE REPORTED ON EVENT DATE. PCU (DEVICE THAT FAILED ON THAT DAY) AND ANOTHER PCU WERE SET TO OPERATE 3 SYRINGE MODULES AND 4 PUMP MODULES. AT THE END OF ATS TESTING IN THE NEXT DAY, PCU SHUT DOWN BUT THE OTHER PCU DID NOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDINAL HEALTH - ALARIS PRODUCTS | POINT-OF-CARE UNIT | FRN | CARDINAL HEALTH ALARIS PRODUCTS | 8000 | ||
| 2 | CARDINAL HEALTH - ALARIS PRODUCTS | POINT-OF-CARE UNIT | FRN | CARDINAL HEALTH - ALARIS PRODUCTS | 8000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |