BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPH190 SYNTHETIC HF DIALYZERHF DIALZER

    MDR report key: 1806812 · Received August 19, 2010

    Report

    Report Number
    1423500-2010-02672
    Event Type
    Injury
    Date Received
    August 19, 2010
    Date of Event
    June 19, 2010
    Report Date
    June 22, 2010
    Manufacturer
    NIPRO CORPORATION *USD*
    Product Code
    KDI
    PMA / PMN Number
    K083778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NIPRO MANUFACTURER RESPONSE INDICATES: THE MANUFACTURING RECORDS, PROCESS INSPECTION RECORDS AND RELEASE INSPECTION RECORDS OF THE LOT CONCERNED WERE REVIEWED AND NO ABNORMALITY WAS FOUND . THE RETAINED SAMPLES OF THE LOT CONCERNED WERE CHECKED VISUALLY AND NO DAMAGE WAS FOUND ON THE FIBERS. AN AIR LEAK TEST WAS IMPLEMENTED UNDER THE FLOODED CONDITION AFTER PRIMING AND NO FIBER LEAK OR LEAK FROM OTHER PLACES WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURER, NIPRO PERFORMED A BATCH REVIEW AND NO PROBLEM WAS FOUND ON THE RECORDS, RETAINED SAMPLES OR PRODUCTION PROCESSES. NIPRO PERFORMED TESTING ON RETAINED SAMPLES AND NO PROBLEM WAS FOUND. THERE WERE NO SAMPLES AVAILABLE TO EVALUATE THE ISSUE. THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE. THIS IS THE SECOND OF TWO COMPLAINTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS DISCARDED AND NO COMPANION SAMPLES ARE AVAILABLE; THEREFORE, AN EVALUATION WILL NOT BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED INFORMATION: THE CORRECT AWARE DATE IS (B)(4) 2010, WHEN BAXTER BECAME AWARE OF SIGNIFICANT BLOOD LOSS MAKING THIS EVENT A REPORTABLE SERIOUS INJURY. ADDITIONAL INFORMATION: THE OTHER DIALYZER WAS REPORTED UNDER 1423500-2010-02671. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A PATIENT EXPIRATION AND REQUEST PICK UP OF THE PERITONEAL DIALYSIS SUPPLIES. THE CAREGIVER INDICATED THE PATIENT HAD EXPIRED LAST WEEK (DATE UNKNOWN). ON (B)(6) 2010 DURING A FOLLOW UP CALL, THE FACILITY NURSE INDICATED THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010 DUE TO THE COMPLAINT OF SYNCOPE. REPORTEDLY, THE PATIENT DECOMPENSATED, WAS INTUBATED AND THE FAMILY LATER CHOSE TO WITHDRAW LIFE SUPPORT. THE PATIENT EXPIRED ON (B)(6) 2010. CAUSE OF DEATH IS UNKNOWN. AN AUTOPSY WAS NOT PERFORMED. THE NURSE INDICATED THERE WAS NO RELATION TO THE PERITONEAL DIALYSIS THERAPY, HOMECHOICE DEVICE, OR ANY BAXTER SOLUTIONS AND THE PATIENT EXPIRATION. NO OTHER INFORMATION IS AVAILABLE REGARDING THIS EVENT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS BLACK MARKS IN THE DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    THE FACILITY PURCHASING AGENT REPORTED XENIUM DIALYZERS LEAKED BLOOD TWICE DURING PATIENT USE AT THE BEGINNING OF THE TREATMENT ON (B)(6) 2010. THE BLOOD LEAKS WERE BOTH FROM THE FIBER. THE BLOOD LEAKS WERE DISCOVERED WHEN THE BLOOD LEAK ALARM WAS NOTED ON THE MACHINE. BOTH WERE CONFIRMED BY A HEMASTIX TEST AT THE HANSON CONNECTOR. THE TOTAL ESTIMATED BLOOD LOSS WAS APPROXIMATELY 400 ML. THE DIALYZER WAS CHANGED AFTER THE FIRST BLOOD LEAK. AFTER THE SECOND BLOOD LEAK, TREATMENT WAS DISCONTINUED AND THE PATIENT DECLINED TO CONTINUE TREATMENT. NO MEDICAL INTERVENTION WAS REQUIRED. THE MACHINE WAS EVALUATED AND NO PROBLEMS WERE IDENTIFIED. THE ACTUAL DIALYZERS WERE BOTH DISCARDED AND NO COMPANION SAMPLES ARE AVAILABLE. THIS REPORT IS FOR THE FIRST BLOOD LEAK WITH THE FIRST DIALYZER.

    Description of Event or Problem · 1

    THE BAXTER TECHNICIAN REPORTED A COLLEAGUE PUMP THAT HAS A FAILURE CODE OF 550:320:654:0000 THAT HAD NO AUDIBLE ALARM. THE REPORTED CONDITION WAS IDENTIFIED DURING SERVICE. THERE WAS NO DOCUMENTED PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.90, WHICH IS CLASSIFIED AS REMEDIATED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPH190 SYNTHETIC HF DIALYZERHF DIALZER DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION *USD* 09H10B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other