MalfunctionFIB
NIPRO SET
Received Jul 8, 2004
Report 8041145-2004-00001 · MDR key 610190
Device
Generic name
Blood Tubing Set
Manufacturer
Nipro (thailand) Corp. Ltd.Model number
A209/V803Catalog number
A209/V803
Lot number
03H20
Product problems
- Leak/Splash
Patient
UNKNOWN
- Blood Loss
Narrative
Description of Event or Problem
BLOOD LEAK ON NIPRO BLOODLINE A209/V803 1/2 TO 3/4 HOURS INTO THE PATIENT TREATMENT. LOSS OF BLOOD ESTIMATE AT ONE PINT OR MORE ON PATIENT AND FLOOR. LOSS WAS FROM VENOUS PATIENT CONNECTION TO CATHETER. VENOUS LINE CHANGED OUT AND PATIENT CONTINUED TO RUN WITHOUT FURTHER PROBLEMS. VENOUS LINE DISCARDED.