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 ScientificModel number
9207Catalog 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.