FDA Adverse Event
Malfunction
Summary report: N
3100 SYRINGE PUMP
MDR report key: 584507
·
Received March 18, 2005
Report
- Report Number
- 9612511-2005-00004
- Event Type
- Malfunction
- Date Received
- March 18, 2005
- Date of Event
- December 3, 2004
- Report Date
- March 18, 2005
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL LTD.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
2004 13:00HRS NOTED ALFENTANIL PUMP HOLD BUTTON LIT UP, NO ONE HAD PRESSED IT. STAFF NURSE PRESSED RUN BUTTON, LIGHT ON PUMP PT DISPLAY WENT OUT. CHECKED VOLUME INFUSED, NONE HAD BEEN INFUSED FOR AN HOUR BUT PUMP HAD NOT ALARMED. ICP HAD BEEN ELEVATED ON AND OFF BUT MORE SO FOR THE PAST HOUR. DOCTOR INFORMED AND TREATMENT GIVEN. ONCE IT WAS KNOWN THAT THE PT HAD HAD NO ALFENTANIL FOR 1 HOUR A BOLUS WAS GIVEN BY THE DOCTOR ICP IMPROVED SLOWLY. PUMP TAKEN OFF AND REPLACED. NO REPORTED LONG TERM PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3100 SYRINGE PUMP | SYRINGE PUMP | FRN | SMITHS MEDICAL INTERNATIONAL LTD. | 3100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |