FDA Adverse Event
Malfunction
Summary report: N
AUTOSYRINGE INFUSION PUMP MODEL AS50
MDR report key: 787947
·
Received December 15, 2004
Report
- Report Number
- 6000001-2004-02089
- Event Type
- Malfunction
- Date Received
- December 15, 2004
- Date of Event
- November 1, 2004
- Report Date
- November 19, 2004
- Manufacturer
- BAXTER HEALTHCARE PTE. LTD.
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BIOMED STATED THAT A PATIENT IN LABOR AND DELIVERY WAS RECEIVING MEDICATION ON THIS PUMP. A FOLLOW UP WITH THE ADDITIONAL CONTACT REVEALED THE MEDICATION INVOLVED WAS PITOCIN WHICH CAUSED THE HEART RATE OF THE UNBORN BABY TO DECREASE. THE INFUSION WAS STOPPED AND MEDICAL INTERVENTION OF AN UNKNOWN DRUG WAS GIVEN SUB-Q TO REVERSE THE REPORTED CONDITION. THE INFUSION OF THE MEDICATION WAS Y'D INTO THE SIGHT WITH IV FLUID ON AN I-MED PUMP. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AUTOSYRINGE INFUSION PUMP MODEL AS50 | INFUSION PUMP | FRN | BAXTER HEALTHCARE PTE. LTD. | 1M8550 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Required Intervention | MEDICATION-PITOCIN| I-MED INFUSION PUMP SERIAL NUMBER UNK |