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U.S. Department of Health and Human Services

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

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SORIN GROUP ITALIA SRL CSC14 BLOOD CARDIOPLEGIA SYSTEM; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
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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 Key9207155
MDR Text Key214556219
Report Number9680841-2019-00035
Device Sequence Number1
Product Code DTR
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
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 Date05/26/2022
Device Catalogue Number025310
Device Lot Number1903280059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/19/2019
Initial Date FDA Received10/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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