BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLER DRAINAGE SET (CS=15 PR)

    MDR report key: 1853144 · Received October 5, 2010

    Report

    Report Number
    1423500-2010-04045
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K791899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A LEAK FOUND IN THE DRAIN BAG. THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT ADDRESSES INCIDENT 3 OF 3. A CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A DRAIN BAG LEAKING. THE CG STATED SHE DID NOT NOTICE THE LEAK UNTIL SHE WOKE UP. THE CG STATED SHE BELIEVED THE EFFLUENT WAS LEAKING RIGHT FROM THE TUBE ITSELF, BUT WAS NOT CERTAIN. THE CG STATED THE ACTUAL PRODUCT HAD BEEN DISCARDED AND SHE HAD ALREADY INFORMED THE CLINIC OF THE ISSUE. THE CG STATED SHE WAS ADVISED TO CONTACT BAXTER TO REQUEST TO HAVE THE CARPETS CLEANED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO SPEAK WITH HOMECARE SERVICES REGARDING CARPET CLEANING. ON (B)(6) 2010, PRODUCT SURVEILLANCE (PS) CONTACTED THE HOME PATIENT'S (HP) WIFE, THE CG, REGARDING THE REPORTED PROBLEM. THE WIFE CONFIRMED THAT NO SAMPLES WERE AVAILABLE. THE WIFE STATED THAT ANOTHER BAG HAD LEAKED FROM THE SAME LOT (MAKING A TOTAL OF 3 REPORTS), BUT SINCE THEN THEY HAVE NOT HAD ANY ISSUES WITH THERAPY. THE WIFE STATED THAT WHEN THE FIRST BAG LEAKED THE FLUID COMPLETELY SATURATED THE CARPET AND THEY HAD TO HAVE IT CLEANED PROFESSIONALLY. (B)(6) PROVIDED THE NUMBER FOR CARPET/ FLOOR CLAIMS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLER DRAINAGE SET (CS=15 PR) SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H10D15115

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR