MAUDE Adverse Event Report: SORIN GROUP ITALIA CSC14 BLOOD CARDIOPLEGIA SYSTEM; HEAT EXCHANGER, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.At the date of the present report, the unit has not been returned to the manufacturer facilities for investigation.The csc14 cardioplegia device p3740j is not distributed in the usa, but it is similar to the csc14 cardioplegia device 025310, which is distributed in the usa (510k#: k012898).Sorin group (b)(4) manufactures the csc14 blood cardioplegia device.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that a foreign particle was found inside the csc14 cardioplegia device during a supplier inspection.As the impurity was found by the supplier, there was no patient involvement.The investigation is on going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that a foreign particle was found inside the csc14 cardioplegia device during a supplier inspection.As the impurity was found by the supplier, there was no patient involvement.

Manufacturer Narrative

Date returned to manufacturer: 01/07/2016.Sorin group (b)(4) manufactures the csc14 blood cardioplegia device.The incident occurred in (b)(6).This medwatch is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that a foreign particle was found inside the csc14 cardioplegia device during a supplier inspection.As the impurity was found by the supplier, there was no patient involvement.The complained unit was returned to sorin group (b)(4) for further investigation.Visual inspection of the returned device confirmed the reported issue.A particle was discovered attached to the bubble trap net of the device.No other abnormalities or defects were identified throughout the visual inspection.The issue resulted from the presence of a small imperfection in the frame around the net of the bubble-trap.Imperfections in the net and the frame that are present during assembly onto to the polycarbonate by ultrasonic welding can cause deformities which generate this kind of particle.Operators are trained to identify imperfections and discard the device in the presence of such a defect.The root cause for this issue was identified to be failure to identify and discard a defective component during manufacturing.The manufacturing department has been formally informed to provide awareness to operators on how to correctly identify non-acceptable components and discard them.Retraining has been conducted and the personnel responsible for this lot have been directly addressed to be made aware of the reported issue.A review of the dhr could not identify and deviations or non-conformities relevant to the issue.No trend has been identified and no further action is required.Sorin group (b)(4) will continue to monitor the market for trends related to this type of issue.

• Brand Name: CSC14 BLOOD CARDIOPLEGIA SYSTEM
• Type of Device: HEAT EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (mo), italy 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola (mo), italy 41037 ; IT 41037
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5240304
• MDR Text Key: 31787318
• Report Number: 9680841-2015-00495
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: N/A
• Device Catalogue Number: P3740J
• Device Lot Number: 1409180120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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