BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2830244 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-04958
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    March 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES OR DEVIATIONS NOTED DURING THE MANUFACTURING PROCESS. THE REPORTED ISSUE WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED, AS A SAMPLE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE AVAILABLE FOR EVALUATION. SINCE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND NO FURTHER INFORMATION ABOUT ANY PRODUCT PROBLEM IS AVAILABLE, NO ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    BAXTER RENAL HOMECARE SERVICES REPRESENTATIVE SENT AN EMAIL TO CORPORATE PRODUCT SURVEILLANCE ON (B)(6) 2012 TO REPORT A CALL RECEIVED ON THE SAME DAY BY THE HOME PATIENT'S (HP) REGISTERED NURSE (RN) TO REPORT THAT THE HOME PATIENT HAS BEEN EXPERIENCING CRACKED MINICAPS. THE RN STATED THAT THE HP HAD GIVEN HER 2 MINICAPS. THE RN HAD THE LOT NUMBER FROM THE LAST MINICAP BUT DID HAVE THE LOT NUMBER FROM THE OTHER MINICAP RECEIVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) ON (B)(6) 2012 REGARDING THE HOME PATIENT'S (HP) CRACKED MINICAPS. THE RN STATED THAT THE HP HAS BEEN FINDING A CRACKED MINICAP IN ALL HER PAST ORDERS SINCE (B)(6). THE RN SAID THAT SHE HAS BEEN CHANGING OUT THE HP'S TRANSFER SET EVERY TIME SHE REPORTED A CRACKED MINICAP. THE RN SAID THE HP HAD DISCARDED THE OTHER SAMPLES. THE RN DID NOT KNOW IF THE HP TURNED THE CAP TOO HARD. THERAPY HAS BEEN GOING WELL SINCE INCIDENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE MONTH OF (B)(6). REPORT 8 OF 9.

    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 GD891721

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR HOMECHOICE