MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-09 for BELZER UW COLD STORAGE SOLUTION BUW-002 manufactured by Preservation Solutions, Inc..
[102337376]
End user was restocking the product (belzer uw cold storage solution, 2 liter bag) in their refrigerator. End user noticed a dark substance between the outer non-sterile dust cover (secondary bag) and the primary solution bag of one (1) unit; determined that the bag was possibly contaminated and not usable. The problem unit was located on the bottom of a box containing a total of five (5) units. Three other boxes of product of the same lot (bce110217) had already been stocked without any other issues or observances. Problem bag was not used and was kept in isolation from other units and returned to the manufacturer (preservation solutions, inc) for evaluation. Preservation solutions, inc. Requested that the unaffected remaining units be quarantined in place out of precaution. Preservation solutions, inc (psi) received the problem unit on january 25, 2018. Evaluation of the bag confirmed that the individual unit was contaminated. Evaluation of the problem unit identified the root cause of the contamination to be a small leak where the injection port is sealed into the primary bag by the raw material vendor. The root cause was confirmed on january 30, 2018. The injection port on the primary bag is not used or manipulated by psi during the aseptic filling of the organ preservation solution into the primary bag. Psi suspended manufacturing of the 2 liter product on january 30, 2018 and ceased selling the 2 liter product on the same date. Inspection of remaining product in psi inventory discovered an additional unit with a leak in the primary bag at the same location as the unit identified by the end user. Psi contacted its raw material bag manufacturer/vendor on january 24, 2018 regarding the leak problem. Psi notified the product distribution companies on january 30 and january 31 to cease shipping the 2 liter product to customers. Testing of a retained unit, kept in isolation at psi, from lot bce110217 and an unused (not the problem bag) returned unit from the end user from lot bce110217 passed a repeat of all product release testing, including sterility. Sterility test results for the retained and the unused (non-problem bag) returned unit were "negative for growth" psi received a report from its raw material bag manufacturer, thermo fisher scientific, on february 16, 2018 that identifies the root cause of the manufacturing defect as a combination of a misaligned pin, heat element failure and an interrupted cycle in the rf machine used to manufacture the bags. Thermo fisher has assured psi that the failure cannot be repeated without all three variables. Thermo fisher has also confirmed that the manufacturing defect is limited to the 2 l bag.
Patient Sequence No: 1, Text Type: N, H10
[102337377]
End user was restocking the product (belzer uw cold storage solution, 2 liter bag) in their refrigerator. End user noticed a dark substance between the outer non-sterile dust cover (secondary bag) and the primary solution bag of one (1) unit; determined that the bag was possibly contaminated and not usable. The problem unit was located on the bottom of a box containing a total of five (5) units. Three other boxes of product of the same lot (bce110217) had already been stocked without any other issues or observances. Problem bag was not used and was kept in isolation from other units and returned to the manufacturer (preservation solutions, inc) for evaluation. Preservation solutions, inc. Requested that the unaffected remaining units be quarantined in place out of precaution. Preservation solutions, inc (psi) received the problem unit on january 25, 2018. Evaluation of the bag confirmed that the individual unit was contaminated. Evaluation of the problem unit identified the root cause of the contamination to be a small leak where the injection port is sealed into the primary bag by the raw material vendor. The root cause was confirmed on january 30, 2018. The injection port on the primary bag is not used or manipulated by psi during the aseptic filling of the organ preservation solution into the primary bag. Psi suspended manufacturing of the 2 liter product on january 30, 2018 and ceased selling the 2 liter product on the same date. Inspection of remaining product in psi inventory discovered an additional unit with a leak in the primary bag at the same location as the unit identified by the end user. Psi contacted its raw material bag manufacturer/vendor on january 24, 2018 regarding the leak problem. Psi notified the product distribution companies on january 30 and january 31 to cease shipping the 2 liter product to customers. Testing of a retained unit, kept in isolation at psi, from lot bce110217 and an unused (not the problem bag) returned unit from the end user from lot bce110217 passed a repeat of all product release testing, including sterility. Sterility test results for the retained and the unused (non-problem bag) returned unit were "negative for growth" psi received a report from its raw material bag manufacturer, thermo fisher scientific, on february 16, 2018 that identifies the root cause of the manufacturing defect as a combination of a misaligned pin, heat element failure and an interrupted cycle in the rf machine used to manufacture the bags. Thermo fisher has assured psi that the failure cannot be repeated without all three variables. Thermo fisher has also confirmed that the manufacturing defect is limited to the 2 l bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000221028-2018-00098 |
| MDR Report Key | 7328657 |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-09 |
| Date of Event | 2018-01-22 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2017-11-02 |
| Date Added to Maude | 2018-03-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SCOTT FISHER |
| Manufacturer Street | 1099 PROCTOR DRIVE |
| Manufacturer City | ELKHORN WI 53121 |
| Manufacturer Country | US |
| Manufacturer Postal | 53121 |
| Manufacturer Phone | 2627236715 |
| Manufacturer G1 | PRESERVATION SOLUTIONS, INC. |
| Manufacturer Street | 1099 PROCTOR DRIVE |
| Manufacturer City | ELKHORN WI 53121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 79378 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BELZER UW COLD STORAGE SOLUTION |
| Generic Name | BELZER UW COLD STORAGE SOLUTION |
| Product Code | KDN |
| Date Received | 2018-03-09 |
| Returned To Mfg | 2018-01-25 |
| Catalog Number | BUW-002 |
| Lot Number | BCE110217 |
| Device Expiration Date | 2019-11-02 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | PRESERVATION SOLUTIONS, INC. |
| Manufacturer Address | 1099 PROCTOR DRIVE ELKHORN WI 53121 US 53121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-09 |