FDA Adverse Event
Summary report: N
CADD-SOLIS
MDR report key: 2222631
·
Received August 9, 2011
Report
- Report Number
- 2222631
- Date Received
- August 9, 2011
- Date of Event
- August 9, 2011
- Report Date
- August 9, 2011
- Manufacturer
- SMITHS MEDICAL
- Product Code
- MEA
- Report Source
- User Facility report
- Reporter Location
- RI, US
Narratives
Description of Event or Problem · 1
WENT INTO PATIENT'S ROOM AT CHANGE OF SHIFT. ONCE IN ROOM, PCA PUMP BEGAN ALARMING, SCREEN WAS RED WITH CODE #48622 VISIBLE ON SCREEN. UNABLE TO SILENCE THE ALARM OR RESET PUMP. PATIENT DISCONNECTED FROM THE INFUSION IMMEDIATELY AND A NEW PUMP REQUESTED. BATTERIES WERE REMOVED FROM THE PUMP IN AN EFFORT TO RESET/STOP THE ALARM FROM CONTINUING. ONCE BATTERIES REMOVED AND REPLACED, THE PCA PUMP WAS ABLE TO BE TURNED ON. WHEN PROMPTED, DURING PROGRAMMING, FOR THE 3 DIGIT PASS CODE (B)(4), THE PUMP RESPONDED WITH MESSAGE THAT IT WAS THE INCORRECT PASS CODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CADD-SOLIS | INFUSION PUMP | MEA | SMITHS MEDICAL | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |