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 No Information (3190)

Event Type  malfunction  

Event Description

Spontaneous non-serious.((b)(4)).

• 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: 5667180
• MDR Text Key: 45601589
• Report Number: 3003708554-2016-00005
• 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: 05/19/2016
• 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