BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2241706 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11967
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 19, 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 COMPLAINT HAS BEEN CONFIRMED FOR CRACKED MINICAP. THE ROOT CAUSE WAS ATTRIBUTED TO THE MANUFACTURING PROCESS. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A NURSE REPORTED A HOME PATIENT(HP) WHO HAD A CRACKED MINI-CAP. THE CAREGIVER(CG) WAS CONTACTED ON (B)(6) 2011. THE CG STATED THAT THE HOME PATIENT(HP) IS NOT SURE HOW THE MINICAP BECAME CRACKED. THE CG STATED THAT THE HP NOTICED THE CRACK IN THE MINI-CAPS WHILE HE WAS WALKING AROUND. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD879924

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR HOMECHOICE