inforMED
InjuryFIB

TRANSDUCER PROTECTOR-DOUBLE HIP FILTER

Received Aug 26, 1996 · Event occurred Aug 6, 1996

Report 36173 · MDR key 36173

Device

Generic name

Transducer Filter

Manufacturer

Gelman Scientific

Model number

9207

Catalog number

04-9207-4 (NMC CATALOG)

Lot number

*

Product problems

  • Device Alarm System
  • Transducer failure

Patient

33 YR

  • Bleeding

Narrative

Description of Event or Problem

APPROX 4 HRS AFTER INITIATION OF DIALYSIS TREATMENT PT HAD VENOUS NEEDLE DISLODGE. BLOOD WAS NOTED ON FLOOR. BLOOD PUMP STOPPED AND LINES WERE CLAMPED. PT WAS SLEEPING AT THE TIME AND WAS BELIEVED TO HAVE JERKED HIS ARM WHILE SLEEPING. PT AROUSABLE THEN LOST CONSCIOUSNESS FOR SEVERAL SECONDS. PT RESPONDED TO SALINE BOLUS AND WAS VERBALLY COMMUNICATIVE AFTER THE EVENT. PT TRANSFERRED TO EMERGENCY ROOM AFTER EVENT, SEEN AND RELEASED. BLOOD LOSS WAS ESTIMATED AT 500 CC. DIALYSIS SYSTEM DID NOT ALARM LOW VENOUS PRESSURE AT TIME OF EVENT. HOWEVER, THE VENOUS PRESSURE MONITORING TRANSDUCER PROTECTOR WAS NOTED TO BE BLOODY AT TIME OF EVENT AND MAY NOT HAVE BEEN MONITORING PROPERLY. FACILITY HAS BEEN HAVING PROBLEMS WITH TRANSDUCERS BACKING UP. TUBING PULLED FROM USE AND EVALUATED BY TECHNICAL DEPARTMENT. ALL ALARMS FUNCTIONING PROPERLY AND CALIBRATIONS VERIFIED. MDR'S BEING DONE ON TRANSDUCER PROTECTOR AND VENOUS BLOODLINE SINCE IT IS UNCLEAR WHICH IS THE SOURCE OF THE PROBLEM. PT RETURNED TO THE DIALYSIS UNIT 8/8/96 AND DIALYZED WITHOUT DIFFICULTY.