MAUDE Adverse Event Report: FRESENIUS KABI AUSTRIA VIASPAN (BELZER UW) COLD STORAGE SOLUTION; VIASPAN (BELZER UW - CSS), PRODUCT CODE: KDL

Lot Number 16II2120

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Event Description

(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.

• Brand Name: VIASPAN (BELZER UW) COLD STORAGE SOLUTION
• Type of Device: VIASPAN (BELZER UW - CSS), PRODUCT CODE: KDL
• Manufacturer (Section D): FRESENIUS KABI AUSTRIA; hafnerstrasse 36; graz, austria 8055 ; AU 8055
• Manufacturer (Section G): FRESENIUS KABI AUSTRIA; hafnerstrasse 36; graz, austria 8055 ; AU 8055
• Manufacturer Contact: james young ; 425 privet road; horsham, PA 19044 ; 2152937263
• MDR Report Key: 5758442
• MDR Text Key: 56406747
• Report Number: 3003708554-2016-00006
• Device Sequence Number: 1
• Product Code: KDL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2016
• Device Lot Number: 16II2120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1