BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS EXTENSION SET SET

    MDR report key: 1884247 · Received June 11, 2010

    Report

    Report Number
    3005789918-2010-00003
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    June 9, 2009
    Report Date
    March 23, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FPA
    PMA / PMN Number
    K830755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVAL: TWO SEALED (B)(4) WALRUS EXTENSION SETS AND TWO NON-ARROW TUBING SETS WERE RETURNED; NO ARROW TUBING WAS SENT FOR EVAL. THE EXTENSION SETS WERE CONNECTED TO THE DISTAL END OF THE TWO NON-ARROW TUBING SETS ALSO RETURNED BY THE CUSTOMER. A STOPCOCK WAS ATTACHED TO THE DISTAL END OF BOTH EXTENSION SETS. NO DEFECTS OR ANOMALIES WERE VISUALLY OBSERVED ON THE TWO RETURNED (B)(4) EXTENSION SETS. THE LUER CORRECTIONS ON BOTH ENDS OF THE EXTENSION SET WERE MADE WITHOUT DIFFICULTY. THE ASSEMBLIES WERE FLUSHED AND PRIMED WITH WATER. THE ASSEMBLIES WERE HUNG SO THAT THE WEIGHT OF THE PRIMED EXTENSION SET CREATED TENSION AT THE LUER CONNECTIONS. THE ASSEMBLIES WERE HUNG FOR SEVEN DAYS AND FLUSHED SEVEN TIMES AT VARIOUS INTERVALS TO SIMULATE HANDLING DURING USE. NO LEAKS OR DISCONNECTS WERE OBSERVED OVER THE TEST INTERVAL. THE REPORT OF DISCONNECTS WITH VARIOUS TUBING PRODUCTS AFTER 2 TO 3 DAYS WAS NOT CONFIRMED THROUGH EVAL OF THE RETURNED SAMPLE, AS THE EXTENSION SETS REMAINED SECURELY ATTACHED TO NON-ARROW TUBING SETS THROUGHOUT SEVEN DAYS OF FUNCTIONAL TESTING. HOWEVER, SINCE THE ACTUAL SETS INVOLVED IN THE REPORTED INCIDENT WERE NOT RETURNED, THE POTENTIAL CAUSE OF THIS ISSUE COULD NOT BE DETERMINED. THIS IS ONE OF 3 RECORDS REFLECTING MULTIPLE OCCURRENCES OF MFR CONTROL NO. (B)(4). ADD'L OCCURRENCES ARE DOCUMENTED AS MDR # 3005789918-2009-00007, MDR # 3005789918-2010-00004. UNTIL (B)(4), 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM (B)(6), 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND (B)(4) REPORTS. PLEASE REFER TO THE MDR FOR THE ORIGINAL COMPLAINT REFERENCED ABOVE FOR THE FOLLOW-UP FOR THIS MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE (B)(4) EXTENSION SET IS FAILING TO HOLD A CONNECTION WITH VARIOUS OTHER TUBING PRODUCTS AFTER 2 TO 3 DAYS. THIS IS HAPPENING IN THE BONE MARROW TRANSPLANT DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALRUS EXTENSION SET SET WALRUS PRODUCTS FPA ARROW INTERNATIONAL INC GF9035757

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK