BELZER UW COLD STORAGE SOLUTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-01-08 for BELZER UW COLD STORAGE SOLUTION manufactured by Preservation Solutions Inc.

Event Text Entries

[96701448] 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.
Patient Sequence No: 1, Text Type: N, H10


[96701449] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1000221028-2017-00088
MDR Report Key7173067
Report SourceDISTRIBUTOR
Date Received2018-01-08
Date of Report2017-09-01
Date Mfgr Received2017-07-24
Date Added to Maude2018-01-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSCOTT FISHER
Manufacturer Street1099 PROCTOR DRIVE
Manufacturer CityELKHORN WI 53121
Manufacturer CountryUS
Manufacturer Postal53121
Manufacturer Phone2627236715
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBELZER UW COLD STORAGE SOLUTION
Generic NameBELZER UW COLD STORAGE SOLUTION
Product CodeKDN
Date Received2018-01-08
Device Availability*
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPRESERVATION SOLUTIONS INC
Manufacturer Address1099 PROCTOR DRIVE ELKHORN WI 53121 US 53121


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention 2018-01-08

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