BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT

    MDR report key: 1210994 · Received October 24, 2008

    Report

    Report Number
    1423500-2008-00874
    Event Type
    Death
    Date Received
    October 24, 2008
    Date of Event
    August 24, 2008
    Report Date
    August 24, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    PMA / PMN Number
    K842885A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVAL. IF ANY FURTHER INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IN 2008, A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) UNIT. THE HOME PATIENT (HP) DID NOT REALIZE HE BECAME DISCONNECTED FROM THE HC. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED IN CLEARING BOTH THE SYSTEM ERROR 2240 AND 2367 ALARMS. THE TSR ADVISED THE HP TO DISCARD THE SUPPLIES. THE HP WOULD START OVER WITH NEW SUPPLIES. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW-UP CALL ON APPROX ONE AND A HALF MONTHS LATER, THE HP'S NURSE INDICATED THE HP DEVELOPED PERITONITIS AND PASSED AWAY ON THE MONTH AFTER THE ORIGINAL MONTH. IT WAS REPORTED THAT ON EARLY THE THAT MONTH, THE HP WENT TO THE HOSP FOR RESTLESSNESS AND CONFUSION FROM NEW MEDICATION TO TREAT PARKINSON'S DISEASE AND WAS DIAGNOSED WITH PERITONITIS. A CULTURE TAKEN OF THE PERITONEAL DIALYSIS (PD) EFFLUENT SHOWED THE CAUSATIVE ORGANISM WAS STAPHYLOCOCCUS AUREUS. THE HP WAS GOING TO HAVE HIS PERITONEAL DIALYSIS (PD) CATHETER REMOVED AND GET A HEMODIALYSIS PORT IN ITS PLACE; HOWEVER, THE HP PASSED AWAY IN THE HOSPITAL PRIOR TO THIS. THE PT'S CAUSE OF DEATH WAS CARDIAC ARREST SECONDARY TO SEPSIS. THE PT WAS NOT CONNECTED TO THE HC UNIT AT THE TIME OF DEATH. THE NURSE ALSO MENTIONED AT THIS TIME THAT ON A WEEK AFTER THE ORIGINAL DATE, THE TRANSFER SET BECAME SEPARATED FROM THE PT LINE. BLOOD CULTURES WERE NOT DONE AT THE HOSP. THE NURSE INDICATED THAT THE PT HAD BEEN ON CONTINOUS CYCLING PERITONEAL DIALYSIS PRIOR TO THE INCIDENT BUT WAS NOT PERFORMING THERAPY AT THE TIME OF DEATH. THE NURSE DID NOT HAVE ANY FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT 78KDJ KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death