FDA Adverse Event
Injury
Summary report: N
MEDFUSION 3500 SYRINGE INFUSION PUMP
MDR report key: 764602
·
Received September 22, 2006
Report
- Report Number
- 1036813-2006-00037
- Event Type
- Injury
- Date Received
- September 22, 2006
- Date of Event
- August 22, 2006
- Report Date
- August 24, 2006
- Manufacturer
- MEDEX
- Product Code
- FRN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS NOT YET BEEN RECEIVED FOR EVALUATION. MEDEX IS UNABLE TO CONFIRM THIS ISSUE WITHOUT BENEFIT OF RETURNED PRODUCT. HOWEVER, THE INVESTIGATION DONE AT THE FACILITY CONCLUDED THAT THIS WAS DUE TO USER ERROR. AN ADDITIONAL REPORT WILL BE SUBMITTED SHOULD INFORMATION BECOME AVAILABLE THAT IMPACTS THE OUTCOME OF MEDEX'S INVESTIGATION.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE NURSE INTENDED TO DELIVER POTASSIUM CLORIDE TO A PATIENT WHO SUBSEQUENTLY SUFFERED CARDIAC ARREST. INCIDENT OCCURRED IN 2006. PUMP HISTORY SHOWED THE USER SELECTED POTASSIUM ACETATE (KAC) FROM THE LIBRARY INSTEAD OF THE INTENDED POTASSIUM CLORIDE (KC1). THE DRUG INFUSED OVER 3 MINUTES (PER LIBRARY SELECTION) INSTEAD OF ONE HOUR AND SENT THE PATIENT INTO CARDIAC ARREST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDFUSION 3500 SYRINGE INFUSION PUMP | SYRINGE INFUSION PUMP | FRN | MEDEX | 3500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |