BEUDAMED
    FDA Adverse Event Death Summary report: N

    POLYFLUX H CAPILLLARY DAILYZER

    MDR report key: 2612692 · Received June 4, 2012

    Report

    Report Number
    9611369-2012-00005
    Event Type
    Death
    Date Received
    June 4, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 8, 2012
    Manufacturer
    GAMBRO DIAYLSATOREN GMBH
    Product Code
    KDI
    PMA / PMN Number
    K043342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GAMBRO POLYFLUX DIALYZER WAS NOT AVAILABLE FOR INVESTIGATION. THERE WERE (B)(4) DIALYZERS PRODUCED AND DISTRIBUTED WORLDWIDE FROM THIS LOT NUMBER. A REVIEW OF THE LOT HISTORY RECORD CONFIRMED THIS LOT WAS PRODUCED AND TESTED WITHOUT ANY NONCONFORMITIES. REVIEW OF GAMBRO'S COMPLAINT HISTORY FILE CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER. GAMBRO RECEIVED NO INFO TO SUGGEST THAT A GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT AND IT DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    A "SELF DIALYSIS" PT IN (B)(6) COMPLETED A FIVE HOUR DIALYSIS TREATMENT AT A (B)(6) FOR SELF DIALYSIS PTS THAT IS MAINTAINED BY THE HOSP. THE PT CALLED THE EMERGENCY SVS AND REPORTED HE COULD NOT STOP THE BLEEDING FROM HIS FEMORAL ACCESS SITE. THE EMERGENCY SVC TEAM FOUND THE PT DEAD UPON THEIR ARRIVAL AT THE COMMUNITY HOUSE. IT APPEARED THE PT EXPIRED FROM A MAJOR BLOOD LOSS FROM HIS FEMORAL ACCESS SITE. THE MACHINE WAS QUARANTINED BY THE CUSTOMER. AS PART OF STANDARD PROCEDURE, A GAMBRO TECHNICAL SVC SUPERVISOR WAS PRESENT DURING THE INSP OF THE MACHINE. IT WAS REPORTED THE DIALYZER AND BLOOD LINES WERE STILL CONNECTED TO THE MACHINE WITHOUT ANY VISUAL ANOMALIES. HOSP PERSONNEL DID NOT BELIEVE THE MACHINE WAS RELATED TO THE PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLUX H CAPILLLARY DAILYZER KDI GAMBRO DIAYLSATOREN GMBH POLYFLUX 210 H 1-6226-H-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death BLOOD TUBING SET: UNK| MONITOR: (B)(4)