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

Catalog Number CA-20070

Device Problems Air Leak (1008); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2016

Event Type  No Answer Provided  

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 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.

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
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP USA, INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14404 w. 65th way; arvada CO 80004
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5972660
• MDR Text Key: 55440092
• Report Number: 1718850-2016-00390
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00803622103681
• UDI-Public: 00803622103681
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: CA-20070
• Device Lot Number: 1509200062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2015
• 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