BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALRUS EXTENSION SET COMPONENT

    MDR report key: 1884200 · Received June 11, 2010

    Report

    Report Number
    3005789918-2010-00020
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    April 7, 2009
    Report Date
    April 7, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: NO SAMPLE WAS RETURNED FOR REVIEW. INVESTIGATION OF SIMILAR COMPLAINT (B)(4) FOUND THAT NO LEAKAGE WAS OBSERVED WHEN THE CAP WAS NOT ATTACHED TO THE VALVE OR WHEN THE CAP WAS SECURELY TIGHTENED ONTO THE VALVE. HOWEVER, LEAKAGE WAS OBSERVED WHEN THE CAP WAS ONLY PARTIALLY SEATED ONTO THE VALVE. THE MALE EXTENSION ON THE INSIDE OF THE CAP IS LONG ENOUGH TO ACTIVATE THE VALVE AND RESULT IN LEAKAGE THROUGH THE LOOSENED CAP. ALSO, THE TETHER ON THE CAP CAUSES SOME RESISTANCE DURING CAP TIGHTENING AND MAY BE A CONTRIBUTING FACTOR TO THE PARTIALLY SEATED CAPS. A DEVICE HISTORY RECORD REVIEW HAS BEEN PERFORMED WITH NO RELEVANT FINDINGS TO THIS ISSUE. THE POTENTIAL CAUSE OF THIS ISSUE IS DESIGN RELATED. THIS ISSUE HAS BEEN REVIEWED WITH THE CUSTOMER AND THEY DO NOT WANT ANY CHANGES OR IN-SERVICES BUT WILL MONITOR THE SITUATION. THIS IS ONE OF 20 RECORDS REFLECTING MULTIPLE OCCURRENCES OF MANUFACTURER CONTROL NO. (B)(4). ADDITIONAL OCCURRENCES ARE DOCUMENTED AS MDR #30050789918-2009-00006, MDR #3005789918-2010-00005, MDR #3005789918-2010-00006, MDR #3005789918-2010-00007, MDR #3005789918-2010-00008, MDR #3005789918-2010-00009, MDR #3005789918-2010-00010, MDR #3005789918-2010-00018, MDR #3005789918-2010-00019, MDR #3005789918-2010-00021, MDR #3005789918-2010-00022, MDR #3005789918-2010-00023, MDR #3005789918-2010-00024, MDR #3005789918-2010-00025, MDR #3005789918-2010-00026, MDR #3005789918-2010-00027, MDR #3005789918-2010-00028, MDR #3005789918-2010-00029, MDR #3005789918-2010-00030. UNTIL JULY 27, 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM JANUARY 1, 2009 THROUGH JULY 27, 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 THEY HAVE BEEN EXPERIENCING DIFFICULTY WITH LEAKING IN THE W22112 TUBING SET. THE LEAKING OCCURS AT THE CAP THAT IS ATTACHED TO THE Y CONNECTION. THIS OCCURRENCE IN THE PATIENT SOMETIMES CAUSES BLOOD, SALINE OR MEDS TO LEAK. THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALRUS EXTENSION SET COMPONENT WALRUS PRODUCTS FPA ARROW INTERNATIONAL INC. GF9013481

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK