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

Catalog Number 025310

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

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 (catalogue number c20174 it mirandola lot 1906070164) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the cardioplegia heat-exchanger 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 cardioplegia heat-exchanger was assembled.The cardioplegia heat-exchanger was available for investigation but clear pictures visibly confirming the reported issue were provided at the submission of the case.Therefore, the device was not requested.Sorin group italia manufactures the csc14 blood cardioplegia heat-exchanger.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

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

Manufacturer Narrative

Livanova received a report about detection of blood in the water compartment of cardioplegia heat exchanger csc14 during procedure.There is not report of any patient injury.Claimed exchanger was not requested.The claimed blood to water leakage has been confirmed based on visual examination of picture provided by the customer.Considering that devices are 100% leak tested during manufacturing, livanova believe the most probable root causes are: (i) minimal material damage in the metal sheet of the heat exchanger ascribable to defective supplied raw material or (ii) isolated operator error in the dispositioning of the not conforming (leaking) unit.To avoid reoccurrence, new vision system for the inspection of the metal sheet to detect possible raw material damages has been implemented at the supplied site.In addition, improved leak test condition monitoring and tracking have been implemented at livanova site in order to improve the device management during testing of the unit.The complained unit has been manufactured before the implementation to the above described corrective actions.The risk has been assessed as acceptable.Livanova will maintain monitoring the market.

Event Description

See initial report.

• 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
• MDR Report Key: 11066410
• MDR Text Key: 241076260
• Report Number: 9680841-2020-00019
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2022
• Device Catalogue Number: 025310
• Device Lot Number: 1903280059
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1