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

Catalog Number 025310

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The csc14 blood cardioplegia heat-exchanger is a non-sterile device assembled into a sterile convenience pack (lot 1905270109) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.The complained csc14 blood cardioplegia heat-exchanger is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The standalone csc14 blood cardioplegia heat-exchanger (catalog number p3740) is registered in the usa (510(k) number: k012898).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.Sorin group (b)(4) manufactures the csc14 blood cardioplegia heat-exchanger.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The complained csc14 was received at livanova facilities and subjected to leak test.The leak test reproduced reported leakage.The returned csc14 was sectioned to identify the source of the leakage: two fissures of naked-eye visible range dimensions were identified in the sectioned metal sheet.Neither trace of corrosion nor any metal degradation could be identified in the metal sheet by the fissures area.Complaint review revealed that this is the second event registered for this issue in last three years with nearly (b)(4) distributed units worldwide.Based on sgi¿s risk analysis procedure, the probability of harm is incredible (less than 0.001%), the overall residual risk of the event is considered acceptable.Livanova investigation suggests the most probable root cause is related to an isolated operator error.To prevent reoccurrence, an awareness session with all operator has been held to improve awareness on this type of issues.In addition, livanova has issued a capa project to implement action to further reduce the already low probability of an operator error during final leak test.

Event Description

Sorin group (b)(4) has received a report that, during a procedure, after the administration of the cardioplegic solution, the perfusionist saw blood in the water compartment of the cardioplegia heat exchanger csc14.There is not report of any patient injury.

• Brand Name: CSC14 BLOOD CARDIOPLEGIA SYSTEM
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 9207155
• MDR Text Key: 214556219
• Report Number: 9680841-2019-00035
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/18/2019

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: 05/26/2022
• Device Catalogue Number: 025310
• Device Lot Number: 1903280059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2019
• 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