BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERITONEAL DIALYSIS CYCLER SET

    MDR report key: 3191075 · Received June 20, 2013

    Report

    Report Number
    8030665-2013-00387
    Event Type
    Death
    Date Received
    June 20, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 22, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #: 13CR08816. BASED ON THE AVAILABLE INFO, NO DEFINITIVE CONCLUSION CAN BE DRAWN AT THIS TIME. CURRENTLY, IT IS UNK IF THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A MEDICAL RECORD REVIEW WAS PERFORMED BY THE POST MARKET CLINICAL DEPARTMENT AND PHYSICIAN OF THE 38 PAGES OF PT'S MEDICAL RECORDS AND TREATMENT DATA PROVIDED. THE PT HAS A HISTORY OF SEVERAL COMORBIDITIES INCLUDING CARDIAC ARTERY DISEASE, CONGESTIVE HEART FAILURE AND DIABETES MELLITUS TYPE 2. THE PT'S DEATH CERTIFICATE WAS REC'D BY THE MFR FOR REVIEW. THE CAUSE OF DEATH WAS DOCUMENTED AS CORONARY ARTERY DISEASE-MI; SECONDARY TO HTN, DM. NO ADD'L INFO HAS BEEN PROVIDED SUCH AS EMS TRANSPORT RECORDS OR LOGS AS WELL AS HOSPITAL ER RECORDS OR LOGS AS WELL AS HOSPITAL ER RECORDS DOCUMENTING TREATMENT PROVIDED TO THE PT. RECORDS OF AUTOPSY HAVE NOT BEEN PROVIDED AND/OR UNK IF PERFORMED. THE PERITONEAL CYCLER (PLANT INVESTIGATION) IS CURRENTLY UNDERGOING EVAL, A SUPPLEMENTAL MDR REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVAL. REFERENCE MDR #'S: 1224850-2013-0001; 1713747-2013-99912; 2937457-2013-00084.

    Description of Event or Problem · 1

    THE PT'S PERITONEAL DIALYSIS RN CALLED TECH SUPPORT AT THE REQUEST OF THE PT'S WIFE TO COORDINATE THE PICKUP OF THE LIBERTY CYCLER SINCE THE PT HAD EXPIRED ON (B)(6) 2013. THE PD RN ADDED THAT THE WIFE STATED THE HUSBAND WAS BY HIMSELF WHEN THE EVENT OCCURRED AND THAT SHE HEARD A MUMBLED NOISE. ADDITIONALLY, SHE STATED THAT THE PT WAS CONNECTED TO THE CYCLER; HOWEVER, AT THE TIME OF THE CALL, SHE COULD NOT PROVIDE ANY ADD'L DETAILS OR CONFIRM THE STATEMENTS MADE BY THE PT'S WIFE. PD RN STATED THAT THE PT HAD AN EXTENSIVE PREEXISTING CARDIAC HISTORY WITH VERY POOR CARDIAC OUTPUT. DUE TO THESE CARDIAC ISSUES, SURGICAL REPAIR WAS A VERY RISKY OPTION AND WAS NOT GOING TO BE PERUSED. ADDITIONALLY, DUE TO OVERALL POOR HEALTH, HE MISSED THE TWO TREATMENTS PRIOR TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280672 PERITONEAL DIALYSIS CYCLER SET FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER SET 13BR08844

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| H| L| R LIBERTY CYCLER SET| DELFLEX SOLUTION