MAUDE Adverse Event Report: SORIN GROUP USA, INC CARDIOPLEGIA ADAPTER CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number	CA-20070
Medical Device Problem Codes	Air Leak (1008); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2016
Additional Manufacturer Narrative
Patient information was not provided.Sorin group received a report that the distal connector of the cardioplegia adapter cannula was not fully bonded and the device was allowing blood out and air in.The device was switched out with a device from a different lot.There was no report of patient injury.The device has been requested for return to sorin group usa for investigation.A follow-up report will be submitted when the investigation is complete.
Event or Problem Description
Sorin group received a report that the distal connector of the cardioplegia adapter cannula was not fully bonded and the device was allowing blood out and air in.The device was switched out with a device from a different lot.There was no report of patient injury.
Additional Manufacturer Narrative
The customer planned to return the device to sorin group usa for evaluation.However, the device has been inadvertently discarded and is no longer available for return.A review of current inventory found that there is no inventory of this lot number available for inspection.The reported lot built in (b)(6) 2015 and consisted of (b)(4) lines that were shipped to numerous facilities.There have been no other occurrences or complaints received for this lot number regarding bonding or leak issues.As the device was not returned, an investigation could not be performed.A root cause was not determined and corrective actions were not identified.A review of the device history record did not identify any deviations or non-conformities relevant to the reported issue.Sorin group usa will continue to monitor for trends related to this type of issue.Device inadvertently discarded.

• Brand Name: CARDIOPLEGIA ADAPTER CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 5972660
• Report Number: 1718850-2016-00390
• Device Sequence Number: 902155
• Product Code: DWF
• UDI-Device Identifier: 00803622103681
• UDI-Public: 00803622103681
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K972503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2016

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: 04/30/2018
• Device Catalogue Number: CA-20070
• Device Lot Number: 1509200062
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2016
• 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