BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2122162 · Received June 13, 2011

    Report

    Report Number
    1423500-2011-07523
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 22, 2011
    Report Date
    May 22, 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE ROOT CAUSE OF THE COMPLAINT IS USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING A FOLLOW UP, ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) . THE PDRN REPORTED THAT THE HP, WHO HAS NEWLY DIAGNOSED DEMENTIA, BECAME CONFUSED DURING THERAPY AND CUT THE PATIENT LINE WHERE THE LINE EXITS THE HC DEVICE, WITH A SCISSORS TO DISCONNECT HIMSELF. THE CARE GIVER REPORTED THE ISSUE THAT NIGHT AND, AFTER INSTRUCTION TO COME TO THE CLINIC, ON (B)(6) 2011 THE TRANSFER SET WAS AGAIN CHANGED AND A SINGLE PROPHYLACTIC DOSE OF INTRAPERITONEAL (IP) VANCOMYCIN 1GM WAS GIVEN. PER THE PDRN, THE HP WAS REPORTEDLY OKAY AT THE TIME OF THIS REPORT WITH NO FURTHER MEDICAL INTERVENTION REQUIRED

    Description of Event or Problem · 1

    THIS REPORT IS FOR USE ERROR .THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT ASSISTANCE TO END THERAPY WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING DWELL. THE HOME PATIENT (HP) WAS IN DWELL 4 OF 4 AND ACCIDENTLY CUT THE PATIENT LINE. THERAPY WAS ENDED. THE BAXTER TECHNICAL REPRESENTATIVE REFERRED THE HP TO THE REGISTERED NURSE (RN). THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 71 YR HOMECHOICE