InjuryFIB
GELMAN PRESSURE TRANSDUCER PROTECTOR
Received Aug 31, 1994
Report 2937457-1994-00001 · MDR key 22806
Device
Generic name
Transducer Protector
Manufacturer
Gelman Sciences, Inc.Model number
20-DTP20Catalog number
08-2--2 (DISTRIBUTOR #)
Lot number
NA
Product problems
- Filter
Patient
*
- Hepatitis
Narrative
Description of Event or Problem
FOUR DIALYSIS PTS AT A CLINIC BECAME INFECTED WITH HEPATITIS. RN SUSPECTS FAILURE OF TRANSDUCER PROTECTORS. ALL PTS USED SAME HEMODIALYSIS MACHINE. BLOOD FOUND INSIDE INTERNAL PRESSURE TRANSDUCER PROTECTOR OF THE LEVEL DETECTOR MODULE. RN SAID THEY HAVE EXPERIENCED MANY T.P'S BACKING UP WITH BLOOD BUT ARE UNAWARE OF ANY INCIDENTS OF ACTUAL RUPTURED T. P. MEMBRANES. THREE OTHER MACHINE WERE FOUND WITH BLOOD INSIDE THE INTERNAL T.P.