PRESERVATION SOLUTIONS INC, (PSI, MANUFACTURER) RECEIVED INFORMATION FROM (B)(4), DISTRIBUTOR) 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 (B)(6) 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 MALE AND ONE FEMALE (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 MALE PATIENT WAS EXPERIENCING UNSPECIFIED COMPLICATIONS 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 (B)(4) 2017 PHONE CONVERSATION. ALL PSI INQUIRIES FOR INFOMATION 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.
D
Patient 1
PRESERVATION SOLUTIONS INC, (PSI, MANUFACTURER) RECEIVED INFORMATION FROM (B)(4), DISTRIBUTOR) 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 (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 (B)(6) 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 MALE AND ONE FEMALE (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 MALE PATIENT WAS EXPERIENCING UNSPECIFIED COMPLICATIONS 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 (B)(6) 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.