BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1930730 · Received December 16, 2010

    Report

    Report Number
    1423500-2010-06960
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) PROBLEM OF A PATIENT THAT NEEDED HELP ENDING THERAPY EARLY. THIS PROBLEM OCCURRED DURING INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AS THE HP STATED THAT HE WAS STARTING HIS THERAPY AND HIS TRANSFER SET CAP CAME OFF. THE HP STATED HE PRESSED STOP ON THE MACHINE AND WENT TO THE CLINIC. THE HP ALSO STATED THAT THEY GAVE HIM ANTIBIOTICS AND A NEW TRANSFER SET CAP. THE HP STATED THAT THE CLINIC INSTRUCTED HIM TO WAIT AT LEAST 6 HOURS BEFORE STARTING THERAPY. THE HP STATED THAT HE WAS CURRENTLY DOING MANUAL EXCHANGES NOW. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010. THE NURSE STATED THE FOLLOWING: THE SAMPLE WAS DISCARDED AND THE PATIENT WENT TO CONNECT THEN NOTICED THE CAP WAS MISSING. THE TRANSFER SET HAD BEEN IN USE LESS THAN 6 MONTHS AND THERE WAS NO PATIENT INJURY. THEY JUST SOAKED THE SET THEN GAVE THE PATIENT A NEW MINICAP AND THERAPY WAS GOING FINE. THE NURSE STATED THE PATIENT MAY HAVE MORE INFORMATION. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2010. THE PATIENT ANSWERED QUESTIONS RELATING TO THE SEPARATION. THE PATIENT STATED THAT THERE WAS A SEPARATION AT THE CATHETER ADAPTER. THE TRANSFER SET HAD BEEN IN USE LESS THAN 6 MONTHS AND THE PATIENT HAD BEEN PERFORMING DIALYSIS AROUND 7 MONTHS AT THE TIME. THE PATIENT PERFORMED AUTOMATED PERITONEAL DIALYSIS AND THE CATHETER ADAPTER WAS PLASTIC WITH NO VISIBLE THREAD DAMAGE. THE CONNECTION WAS DONE AT THE HOSPITAL WITH A CLAMP AND IT WAS NOT REATTACHED. THE PATIENT WAS PERFORMING THERAPY AT THE TIME OF THE SEPARATION AND HE STATED HE COULD HAVE BEEN DUE TO EXERCISE THAT MAY HAVE LOOSENED IT OVER TIME. THE CATHETER WAS TAPED TO THE BODY AND THE LOT NUMBER WAS UNKNOWN AND SAMPLE WAS DISCARDED. THE PATIENT WAS GIVEN ANTIBIOTICS FOR 6 HOURS AND THEN PERFORMED A MANUAL EXCHANGE. PRODUCT SURVEILLANCE CONTACTED THE CLINIC ON (B)(6) 2010. BAXTER WANTED TO CLARIFY THE MINICAP FALLING OFF IN THE EVENT DESCRIPTION WAS THE EVENT OF THE TRANSFER SET SEPARATION. THE NURSE CONFIRMED THERE WAS NOT A MINICAP THAT FELL OFF BUT RATHER A TRANSFER SET SEPARATION AT THE CATHETER ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR PD CYCLER