BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1970612 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-01014
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED NOT TO BE AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4).THIS REPORT WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT CONDUCTED AS THE LOT INFORMATION WAS UNKNOWN BY THE CUSTOMER. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORT HAS 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

    THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUESTING ASSISTANCE TO END THERAPY ON THE HOMECHOICE (HC) UNIT. THE HP STATED HE WAS READY TO CONNECT BUT DID NOT CONNECT BECAUSE THE CAP WAS OFF THE PATIENT LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY ON THE HC. ON (B)(4) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THE NIGHT OF THIS INCIDENT, HE SET UP HIS THERAPY AS NORMAL; HOWEVER, WHEN HE WENT TO CONNECT, HE REALIZED HIS MINICAP HAD FALLEN OFF HIS TRANSFER SET. THE HP STATED HE JUST NEEDED ASSISTANCE TO END THERAPY SO HE COULD BREAK DOWN HIS SET UP. THE HP STATED HIS TRANSFER SET WAS CLOSED. THE HP CONFIRMED HE NOTIFIED HIS NURSE AND WAS ADVISED TO PUT ON ANOTHER CAP PRIOR TO COMPLETING A MANUAL DRAIN THAT NIGHT. THE HP CONFIRMED THE CAP FALLING OFF WAS AN ISOLATED INCIDENT. THE HP STATED HE BELIEVED HE MAY NOT HAVE TIGHTENED IT COMPLETELY. THERE WAS NO MEDICAL INTERVENTION AND NO ADVERSE EVENT RESULTED FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR PERITONEAL DIALYSIS TRANSFER SET