MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-29 for VIASPAN (BELZER UW) COLD STORAGE SOLUTION manufactured by Fresenius Kabi Austria.
[56406745]
Patient Sequence No: 1, Text Type: N, H10
[56406747]
(b)(4). On 22-apr-2016 spontaneous, not serious report ((b)(4)). Source product name: viaspan (belzer uw) cold storage solution, not applicable. On 22-apr-2016, qas received notification of this report via live call from hospital pharmacy. Complainant stated that they received teva product on 08-mar-2016. She stated that 3 bags were leaking from all over. She stated that they noticed these leakages on 21-apr-2016. She stated that there were 3 defective bags; all were from same lot #. She provided lot number as 16ii2120 and confirmed the expiry date of teva product as 2016 - sep. Upon asking she declined to provide the exact locations of leakage, she stated that she is not going to touch bags or check those locations. She declines to provide more details about sterility compromise, whether sterility of bags was compromised or not. She stated that she can send those bags to teva for further investigation, she declined pics. She asked for (b)(6) label via email. She was seeking reimbursement for 3 bags. She was in hurry and stated that as of now she has only this information with her. On 27-apr-2016: serious: the reporter provided additional information: "we had a total of 3 bags fail last wednesday night. Our transplant team had an patient and needed to take the bags with them. It did cause delays and they had to use alternate therapy. Two of the bags basically exploded all over the pharmacist when the overwrap was removed. The other bag was leaking from a corner when they were getting ready to give it to the team. The transplant team has noted other bags leaking but they were not reported to us so we could report them. Please let me know if you need any additional information. I have sent the return product back on monday. " teva comment: leakage from the product bags and the problem with bags exploding resulted in a delay in preparation of the transplant graft, potentially contributing risk to the viability of the transplant graft, and a risk to the patient recipient. In addition leakage and exploding bags resulted in exposure to team members preparing the transplant graft for transport. A causal role for viaspan for the events device leakage, device failure, device malfunction, delayed engraftment, and occupational exposure can not be excluded. Causality: the events device leakage, device failure, device malfunction, delayed engraftment, and occupational exposure are assessed as possibly related to viaspan. The event intercepted medication error is assessed as not related. On 29-apr-2016: the reporter provided additional information: "i am not aware of any injury to those involved. " teva: no medical comment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003708554-2016-00006 |
| MDR Report Key | 5758442 |
| Date Received | 2016-06-29 |
| Date of Report | 2016-05-19 |
| Date Mfgr Received | 2016-04-22 |
| Date Added to Maude | 2016-06-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES YOUNG |
| Manufacturer Street | 425 PRIVET ROAD |
| Manufacturer City | HORSHAM PA 19044 |
| Manufacturer Country | US |
| Manufacturer Postal | 19044 |
| Manufacturer Phone | 2152937263 |
| Manufacturer G1 | FRESENIUS KABI AUSTRIA |
| Manufacturer Street | HAFNERSTRASSE 36 |
| Manufacturer City | GRAZ, AUSTRIA 8055 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 8055 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIASPAN (BELZER UW) COLD STORAGE SOLUTION |
| Generic Name | VIASPAN (BELZER UW - CSS), PRODUCT CODE: KDL |
| Product Code | KDL |
| Date Received | 2016-06-29 |
| Returned To Mfg | 2016-04-26 |
| Lot Number | 16II2120 |
| Device Expiration Date | 2016-09-30 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FRESENIUS KABI AUSTRIA |
| Manufacturer Address | HAFNERSTRASSE 36 GRAZ, AUSTRIA 8055 AU 8055 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-29 |