MAUDE Adverse Event Report: SORIN GROUP USA, INC AORTIC ARCH CANNULAS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Catalog Number RA-1137

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2016

Event Type  No Answer Provided  

Manufacturer Narrative

There was no patient involvement.Unique identifier (udi) number: (b)(4).This complaint was initially evaluated as non-reportable, as the presence of particulates is not a reportable condition.The residue identified in the visual inspection was initially identified as priming solution residue, which is also not a reportable condition.However, during follow-up communication with the sorin group representative, it was determined that the customer may not have primed the circuit.As it could not be confirmed whether or not the unit was primed, the event was re-evaluated as reportable due to the presence of an unidentified residue in the device.The investigation is still ongoing.A follow-up report will be submitted when the investigation is complete.Evaluation is in process.

Event Description

Sorin group received a report that white particles were discovered on the aortic arch cannula during priming.Upon review of the returned complaint product, white particles could not be identified.However, visual inspection identified white residue which appeared to be deposits of prime solution.There was no patient involvement.

Manufacturer Narrative

Due to the length of time taken to return the device for evaluation and the lack of information regarding the storage and handling of the sample prior to receipt at sorin group usa, it is unclear of the residue identified during the visual inspection was representative of the product condition noted by the customer in the complaint.Further evaluation of the particulate was not performed because the reliability of the sample source could not be determined, and the integrity of the product could not be guaranteed.While the sorin group representative for the facility did not believe that the device had been primed, this could not be confirmed, and the evidence strongly suggests that the device had been primed and the visible particulate identified during the visual inspection was priming residue.As the information regarding the use of the device was not able to be clarified, an exact root cause could not be determined and corrective actions were not identified.The device history record was inspected and no deviations or non-conformities were identified related to the reported issue.Research into the build of this product line found that (b)(4) additional cannula have been manufactured, packaged and shipped since the receipt of this complaint.There have been no other reports of particulate found in these devices.Sorin group usa will continue to monitor for trends related to this type of issue.

• Brand Name: AORTIC ARCH CANNULAS
• 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.; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6104738
• MDR Text Key: 59981494
• Report Number: 1718850-2016-00398
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943934
• 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: 10/18/2016

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: 02/28/2019
• Device Catalogue Number: RA-1137
• Device Lot Number: 1605400082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2016
• 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