BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELZER UW COLD STORAGE SOLUTION

    MDR report key: 7173059 · Received January 8, 2018

    Report

    Report Number
    1000221028-2017-00084
    Event Type
    Injury
    Date Received
    January 8, 2018
    Report Date
    September 1, 2017
    Manufacturer
    PRESERVATION SOLUTIONS, INC.
    Product Code
    KDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRESERVATION SOLUTIONS INC, (PSI, MANUFACTURER) RECEIVED INFORMATION FROM (B)(4) ON JULY 24, 2017 VIA EMAIL THAT (B)(4) HAD RECEIVED A COMPLAINT REGARDING BELZER UW COLD STORAGE SOLUTION. THE INITIAL INFORMATION PROVIDED TO PSI INDICATES THAT (B)(6) MEDICAL CENTER ((B)(6), USER) IN SPOKANE, WASHINGTON KNOWINGLY USED BELZER UW COLD STORAGE SOLUTION OFF-LABEL ON A HEART TRANSPLANT. POST-OPERATION, THERE WAS DIFFICULTY RESTARTING THE HEART. PSI CONTACTED (B)(6) VIA THE EMAIL PROVIDED BY (B)(4) ON JULY 26, 2017 WITH A LIST OF QUESTIONS REGARDING THE COMPLAINT. (B)(6) CONTACTED PSI BY PHONE ON JULY 28, 2017 AND INSINUATED THAT THE QUESTIONS WOULD BE ANSWERED IN THE COMING DAYS. DURING THE PHONE CALL, PSI DISCOVERED THAT THERE WERE TWO PATIENTS, ONE FEMALE AND ONE MALE (FORM 3500A FILED SEPARATELY) EXPERIENCING COMPLICATIONS AFTER UNDER GOING HEART TRANSPLANTS. BOTH HEART TRANSPLANTS KNOWINGLY USED THE BELZER UW COLD STORAGE SOLUTION OFF-LABEL. AS OF (B)(6) 2017, THE FEMALE PATIENT WAS EXPERIENCING RIGHT VENTRICLE/PULMONARY PROBLEMS AND WAS IN A MEDICALLY INDUCED COMA. (B)(6) INDICATED THAT BOTH HEARTS CAME FROM THE SAME DONOR HOSPITAL. PSI HAS BEEN UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION, OR ANSWERS TO THE QUESTIONS ASKED, FROM (B)(6) SINCE THE JULY 28, 2017 PHONE CONVERSATION. ALL PSI INQUIRIES FOR INFORMATION AND ANSWERS TO THE QUESTIONS HAVE BEEN MET WITH GENERALIZED RESPONSES STATING THAT THE QUESTIONS HAVE BEEN ANSWERED BUT ARE CURRENTLY UNDERGOING REVIEW BY (B)(6). PSI WILL CONTINUE TO FOLLOW-UP WITH (B)(6) AS PART OF ITS INVESTIGATION.

    Description of Event or Problem · 1

    PRESERVATION SOLUTIONS INC, (PSI, MANUFACTURER) RECEIVED INFORMATION FROM (B)(4) ON JULY 24, 2017 VIA EMAIL THAT (B)(4) HAD RECEIVED A COMPLAINT REGARDING BELZER UW COLD STORAGE SOLUTION. THE INITIAL INFORMATION PROVIDED TO PSI INDICATES THAT (B)(6) MEDICAL CENTER ((B)(6), USER) IN (B)(6) KNOWINGLY USED BELZER UW COLD STORAGE SOLUTION OFF-LABEL ON A HEART TRANSPLANT. POST-OPERATION, THERE WAS DIFFICULTY RESTARTING THE HEART. PSI CONTACTED (B)(6) VIA THE EMAIL PROVIDED BY (B)(4) ON JULY 26, 2017 WITH A LIST OF QUESTIONS REGARDING THE COMPLAINT. (B)(6) CONTACTED PSI BY PHONE ON JULY 28, 2017 AND INSINUATED THAT THE QUESTIONS WOULD BE ANSWERED IN THE COMING DAYS. DURING THE PHONE CALL, PSI DISCOVERED THAT THERE WERE TWO PATIENTS, ONE FEMALE AND ONE MALE (FORM 3500A FILED SEPARATELY) EXPERIENCING COMPLICATIONS AFTER UNDER GOING HEART TRANSPLANTS. BOTH HEART TRANSPLANTS KNOWINGLY USED THE BELZER UW COLD STORAGE SOLUTION OFF-LABEL. AS OF (B)(6) 2017, THE FEMALE PATIENT WAS EXPERIENCING RIGHT VENTRICLE/PULMONARY PROBLEMS AND WAS IN A MEDICALLY INDUCED COMA. (B)(6) INDICATED THAT BOTH HEARTS CAME FROM THE SAME DONOR HOSPITAL. PSI HAS BEEN UNABLE TO OBTAIN ANY ADDITIONAL INFORMATION, OR ANSWERS TO THE QUESTIONS ASKED, FROM (B)(6) SINCE THE JULY 28, 2017 PHONE CONVERSATION. ALL PSI INQUIRIES FOR INFORMATION AND ANSWERS TO THE QUESTIONS HAVE BEEN MET WITH GENERALIZED RESPONSES STATING THAT THE QUESTIONS HAVE BEEN ANSWERED BUT ARE CURRENTLY UNDERGOING REVIEW BY (B)(6). PSI WILL CONTINUE TO FOLLOW-UP WITH (B)(6) AS PART OF ITS INVESTIGATION. NO NEW RELEVANT INFORMATION AS OF JANUARY 5, 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15144 BELZER UW COLD STORAGE SOLUTION BELZER UW COLD STORAGE SOLUTION KDN PRESERVATION SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R BELZER UW COLD STORAGE SOLUTION