BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1871288 · Received October 15, 2010

    Report

    Report Number
    1423500-2010-04438
    Event Type
    Death
    Date Received
    October 15, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A SAMPLE IS NOT AVAILABLE.A 510(K) NUMBER WILL NOT BE PROVIDED EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT BY A PATIENT'S FAMILY FROM (B)(6) OF PERITONITIS IN A MALE PATIENT COINCIDENT WITH DIANEAL PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE, THE PATIENT BEGAN DIANEAL THERAPY. ON (B)(6)2010, THE PATIENT'S FAMILY CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AND STATED THAT THE PATIENT WAS ADMITTED TO A HOSPITAL URGENTLY. ON (B)(6)2010, THE PATIENT?S FAMILY CONTACTED BAXTER (B)(4) TECHNICAL SERVICE CENTER AGAIN AND STATED THAT THE PATIENT WAS ADMITTED TO A HOSPITAL FOR PERITONITIS. FOLLOW-UP INFORMATION RECEIVED FROM THE PATIENT'S FAMILY ON (B)(6)2010 IS AS FOLLOWS: THE PATIENT'S FAMILY STATED THAT THE PATIENT PASSED AWAY AND ASKED TO ARRANGE PICK UP THE PATIENT'S HOMECHOICE (HC) DEVICE AND PD SOLUTIONS. FOLLOW-UP INFORMATION RECEIVED FROM A PHYSICIAN ON (B)(6)2010 IS AS FOLLOWS: IN (B)(6) 2009, THE PATIENT BEGAN DIANEAL-N PD-4 1.5 AND EXTRANEAL THERAPIES. ON (B)(6)2010, THE PATIENT DEVELOPED PERITONITIS AND WAS ADMITTED TO THE HOSPITAL. HE WAS TREATED WITH A LAVAGE, HEPARIN, AND UNSPECIFIED ANTIBIOTICS. ON (B)(6)2010, DIANEAL N AND EXTRANEAL WERE DISCONTINUED. ON (B)(6)2010, THE PATIENT DIED DUE TO CARDIAC FAILURE. THE TREATMENT FOR THE FATAL CARDIAC FAILURE WAS NOT REPORTED. AS OF (B)(6)2010, THE PERITONITIS DID NOT RESOLVE. THE PHYSICIAN CONSIDERED THAT BOTH EVENTS WERE NOT RELATED TO DIANEAL N AND EXTRANEAL THERAPIES. THE PHYSICIAN CONSIDERED THE PERITONITIS WAS CAUSED BY THE PATIENT'S UNSTERILE TECHNIQUE DUE TO THE PATIENT'S ADVANCED AGE AND MEDICAL HISTORY OF DEMENTIA. THE PHYSICIAN ALSO CONSIDERED THAT THE PERITONITIS MAY HAVE AFFECTED THE HEART AND LED TO THE FATAL EVENT. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFO THAT ONE DAY POST IMPLANT THIS LEAD EXHIBITED LOSS OF CAPTURE AT MAX OUTPUTS, NON SENSING AND RISING IMPEDANCE. THE LEAD WAS FOUND TO BE DISLODGED. A REVISION PROCEDURE IS SCHEDULED FOR THE NEXT DAY. TO DATE, THERE HAVE BEEN NO ADVERSE PT EFFECTS REPORTED. AT THIS TIME, THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFO BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death DIANEAL-N PD-4 1.5 AND EXTRANEAL THERAPIES