FDA Adverse Event
Malfunction
Summary report: N
CENTRY SYSTEM BLOOD TUBING
MDR report key: 22583
·
Received June 20, 1995
Report
- Report Number
- MW1006291
- Event Type
- Malfunction
- Date Received
- June 20, 1995
- Date of Event
- June 2, 1995
- Report Date
- June 2, 1995
- Manufacturer
- COBE RENAL CARE, INC.
- Product Code
- FJK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- HI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
AFTER RETRANSFUSION (BLOOD RETURNED TO PT), DIALYSIS WAS COMPLETED. RPTR ABOUT TO REMOVE TUBING FROM MACHINE WHEN THE TUBING (MED PORT), ATTACHED TO TOP PART OF VENOUS CHAMBER, FELL OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTRY SYSTEM BLOOD TUBING | BLOOD TUBING | FJK | COBE RENAL CARE, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |