inforMED
InjuryFIB

GELMAN PRESSURE TRANSDUCER PROTECTOR

Received Aug 31, 1994

Report 2937457-1994-00001 · MDR key 22806

Device

Generic name

Transducer Protector

Model number

20-DTP20

Catalog 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.