BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 2830272 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-04964
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    September 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

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THE LOT NUMBER WAS UNKNOWN, A BATCH REVIEW COULD NOT BE PERFORMED.ADDITIONAL INFORMATION: THE REPORTED PROBLEM OF DAMAGE WAS CONFIRMED. A SAMPLE WAS RETURNED TO BAXTER. VISUAL EXAMINATION CONFIRMED A CRACK IN THE CAP AND DURING PRESSURE TESTING A LEAK WAS DETECTED. THE REPORTED COMPLAINT WAS CONFIRMED. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: THE ROOT CAUSE WAS IDENTIFIED TO BE USER ERROR, BECAUSE THE MINICAP CRACKED DUE TO OVER-TIGHTENING ON THE TRANSFER SET. ADDITIONAL INFORMATION - PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) REGARDING RETURN OF THE CRACKED MINICAP. THE RN SAID SHE DID NOT FEEL THAT HOME PATIENT WAS OVER TIGHTENING BUT WOULD REVIEW THE PROPER PROCEDURES AGAIN WITH THE HOME PATIENT WHEN SHE COMES TO CLINIC AGAIN. NO ADDITIONAL INFORMATION PROVIDED. A LABELING REVIEW HAS BEEN PERFORMED, FINDING THAT CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO THE PREVENTION OF THE SUSPECTED USE ERROR.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. THE LOT NUMBER IS KNOWN AND A BATCH REVIEW WILL BE PERFORMED. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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)(4) 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 2 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 GD892810

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR HOMECHOICE