MAUDE Adverse Event Report: SORIN GROUP USA, INC CUSTOM PERFUSION TUBING SET; CARDIOPULMONARY BYPASS CUSTOM TUBING KIT

Catalog Number	044030000
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sorin group received a report that the arterial filter was found to have been placed backwards into the line of the custom perfusion tubing set during priming.There was no patient involvement.The involved device has been returned to sorin group usa for investigation.A supplemental medwatch report will be submitted when the investigation is complete.
Event or Problem Description
Sorin group received a report that the arterial filter was found to have been placed backwards into the line of the custom perfusion tubing set during priming.There was no patient involvement.
Additional Manufacturer Narrative
Visual inspection of the returned product confirmed that the arterial filter was connected backwards relative to the print specifications.After review of the work-flow used in the assembly of this av line, it was concluded that the loop had been attached incorrectly, which resulted in the backwards filter.There was no additional inventory of this lot available for further inspection.Follow-up communication with the customer revealed that this was the only pack that had the issue.This lot number was shipped to this facility only.This issue was caused by a manufacturing error.The individual responsible for assembling this line was identified based on the reported lot number and retraining was performed.Sorin group will continue to monitor for trends related to this type of issue.

• Brand Name: CUSTOM PERFUSION TUBING SET
• Common Device Name: CARDIOPULMONARY BYPASS CUSTOM TUBING KIT
• Manufacturer (Section D): SORIN GROUP USA, INC; 14401 w. 65th way; arvada CO 80004
• MDR Report Key: 6059784
• Report Number: 1718850-2016-00395
• Device Sequence Number: 360465
• Product Code: DWE
• UDI-Device Identifier: 00803622126017
• UDI-Public: 00803622126017
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 044030000
• Device Lot Number: 1620000097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2016
• Supplement Report FDA Received Date: 12/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1