BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2183476 · Received July 29, 2011

    Report

    Report Number
    1423500-2011-09962
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE CAUSE WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THE PATIENT LINE BECAME DISCONNECTED FROM THE CATHETER. THE TSR RECOMMENDED THE HP CONTACT THE REGISTERED NURSE (RN). THE HP STATED THAT HE DID CONTACT THE RN. THE TSR RECOMMENDED THE HP CONTACT BAXTER AND THE RN IF THAT OCCURRED AGAIN. THE HP CONTACTED PRODUCT SURVEILLANCE ON (B)(6) 2011 REGARDING THE CONNECTION ISSUE. THE HP STATED THAT HE DURING HIS SLEEP THE PATIENT LINE BECAME DISCONNECTED. THE HP STATED HE CONTACTED HIS PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) FIRST AND SHE ADVISED HIM TO END THERAPY AS HE WAS IN HIS 3RD CYCLE. THE HP STATED HE WENT IN THE FOLLOWING DAY TO SEE THE PD RN. THE HP RESUMED THERAPY ON THE CYCLER THE FOLLOWING NIGHT WITHOUT ANY PROBLEMS. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOMECHOICE