FDA Adverse Event
Malfunction
Summary report: N
DIALYZER MEMBRANES
MDR report key: 1012993
·
Received February 19, 2008
Report
- Report Number
- 1012993
- Event Type
- Malfunction
- Date Received
- February 19, 2008
- Date of Event
- January 21, 2008
- Report Date
- February 18, 2008
- Manufacturer
- FRESENIUS MEDICAL CARE NORTH AMERICA
- Product Code
- FII
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
BLOOD LEAK NOTED AT INITIATION OF DIALYSIS. RNS TO THE CHAIRSIDE IMMEDIATELY TO CONFIRM THE BLOOD LEAK. THE DIALYSATE WAS CHECKED WITH A REAGENT STRIP AND FOUND THE DIALYSATE TO BE POSITIVE FOR BLOOD. THE TREATMENT WAS IMMEDIATELY TERMINATED AROUND THE TWO MINUTE MARK. THE BLOOD WAS NOT RETURNED AND THE DIALYSIS MACHINE WAS IMMEDIATELY PULLED FOR SERVICE. THERE WAS APPROXIMATELY 250CC BLOOD THAT WAS NOT RETURNED TO THE PATIENT DUE TO THE RUPTURED DIALYZER MEMBRANES. THE PATIENT'S BLOOD PRESSURE WHEN DIALYSIS RE-INITIATED ON A NEW MACHINE WAS141/76. THE PATIENT DENIES ANY SIGNS OF LIGHT HEADEDNESS OR DIZZINESS POST TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIALYZER MEMBRANES | DIALYSIS MACHINE | FII | FRESENIUS MEDICAL CARE NORTH AMERICA | NA | 905268 | |
| 2 | HIGH FLUX OPTIFLUX | MEMBRANE, HEMODIALYSIS | KDI | FRESENIUS MEDICAL NORTH AMERICA | * | 7SU309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | DIALYSIS| DIALYSIS |