BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYZER BLOOD PORT ADAPTORS NONSTERIL

    MDR report key: 163509 · Received April 19, 1998

    Report

    Report Number
    8030665-1998-00715
    Event Type
    Injury
    Date Received
    April 19, 1998
    Date of Event
    February 5, 1998
    Report Date
    March 31, 1998
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FJK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PIR#9800684-SAMPLE HAS BEEN DISCARDED, WILL REQUEST A COMPANION SAMPLE. 4/20-SAMPLE NOT YET RETURNED. 4/23-COMPANION SAMPLES (13) REC'D FOR EVALUATION. THE SAMPLES WERE VISUALLY INSPECTED ACCORDING TO SPEC. FOR ANY MFG DEFECTS. NONE WERE NOTED, ALL MET VISUAL SPEC. THE ADAPTERS WERE DIMENSIONALLY INSPECTED ACCORDING TO SPEC AND ALL MET DIMENSIONAL SPECS. THE SAMPLES WERE THEN SUBMITTED TO AN UNDER WATER AIR PRESSURE LEAK TEST ACCORDING TO PROCEDURE. ALL SAMPLES MET SPECS. WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND WITHOUT A LOT NUMBER, CO WAS UNABLE TO CONFIRM THE CUSTOMER'S STATED PROBLEM, OR DETERMINE IF THERE WAS A RELATED MFG ISSUE. ALL OF THE COMPANION SAMPLES PERFORMED ACCORDING TO SPECS. THE SUPPLIER OF ADAPTER HAD BEEN NOTIFIED OF THE COMPLAINT. QUALITY SYSTEMS WILL MONITOR THIS ISSUE IN FUTURE TRENDING. THE CUSTOMER HAS BEEN SENT A F/U LETTER AND HAS BEEN ENCOURAGED TO RETAIN ALL SAMPLES IN ORDER TO MORE EFFECTIVELY EVALUATE ANY FUTURE COMPLAINTS. THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    RECEIVED NOTICE OF COMPLAINT CONCERNING ABOVE PRODUCT FROM DIRECTOR OF NURSING. STATES THAT THE ADAPTOR HAD BEEN IN USE FOR SOME TIME (ACTUAL # OF USES IS UNKNOWN) AND THEREFORE THE LOT NUMBER IS UNKNOWN. REPORTS THAT DURING A PT TREATMENT, BLOOD APPARENTLY LEAKED FROM A HAIRLINE CRACK IN THE ADAPTOR. THE BLOOD WAS FOLLOWING THE PATH OF THE VENOUS LINE AND DRIPPING ONTO THE FLOOR ON THE SIDE OF THE MACHINE THAT WAS NOT IN VIEW OF THE CLINIC STAFF. APPROXIMATELY 200 CC OF BLOOD LEAKED ONTO THE FLOOR BEFORE IT WAS NOTICED. THE DIRECTOR OF NURSING REPORTS THAT SHE HAS HAD MULTIPLE COMPLAINTS FROM THE STAFF REGARDING ADAPTORS CRACKING. THE DIRECTOR OF NURSING REVIEWED THE PROCEDURES THAT THE STAFF FOLLOWS AND FOUND THAT IN SOME CASES THE EXTENSION TUBING CONNECTING THE ARTERIAL LINE TO THE ADAPTOR DURING REUSE WAS NOT BEING USED. THE DIRECTOR OF NURSING FEELS THAT OTHER POSSIBILITIES INCLUDE THE ADAPTORS BEING TORQUED TOO TIGHT, INCUBATION/HEAT, THE REUSE PROCESS (FORMELDEHYDE). THE DIRECTOR OF NURSING ALSO STATES THAT THE LEAKS ARE NOT NOTED DURING PRIMING, BUT OCCUR ONCE THE BLOOD FLOW IS INCREASED AND THE LEAK OCCURS DUE TO THE INCREASED PRESSURE. THE ACTUAL SAMPLE IN THIS EVENT HAS BEEN DISCARDED. MEDWATCH FILED FOR BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYZER BLOOD PORT ADAPTORS NONSTERIL ACCESSORY FJK ERIKA DE REYNOSA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other BLOODLINE/ DIALYSIS 3X/WEEK.| FRESENIUS 2008E MACHINE, F8 DIALYZER, NMC