MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL CSC14 CARDIOLOGIA HEAT EXCHANGER

Model Number 025310

Device Problems Contamination (1120); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2023

Event Type  malfunction  

Event Description

Sorin group italia has received a report that, during the priming, white particles come out from csc14 in to the tubings via saline solution.There was no patient involvement.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.D.4.The csc14 blood cardioplegia system is a non-sterile device assembled into a sterile convenience pack (item: in00211; lot: 2301270139) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the csc14 blood cardioplegia was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.G.5.The complained csc14 blood cardioplegia is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone csc14 blood cardioplegia (catalog number: p3740) is registered in the usa (510(k) number: k012898).H.4.The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the csc14 blood cardioplegia system was assembled.H.10.Sorin group italia manufactures the csc14 blood cardioplegia system.The incident occurred finland.Through follow-up communication, livanova learned that white floating particles were eluted from line tubing connected to outlet port of the heat exchanger (bottom area) and not from purge port on top of the unit.Complained substances are still inside the tubing connections with csc14, immersed in the saline solution, and are available for further analysis.No definitive conclusion could be reached about the source of these materials (accidentally hidden inside the heat exchanger during manufacturing and become evident following the flow of saline solution or already present inside line tubing connection to heat exchanger or precipitates of priming solution).The involved device has been requested for return to sorin group italia for investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Manufacturer Narrative

Verification of manufacturing records showed that noticed unit was released as conform according to specifications.Review of livanova complaints database identified no other similar issue notified for batch concerned from the market out of (b)(4) total units sold worldwide, thus any manufacturing quality deviation can be excluded.Visual inspection of returned part revealed the presence of multiple whitish spots in the inner surface of csc14 outlet port and line.Device was dried with compressed air applied at the inlet port to collect samples in a petri dish but no physical residue was washed out.Tubing was then sectioned to manually isolate any solid material by tweezer but no traces of complained particles were detected.Whitish spots easily dissolved after contact with tweezer itself.Based on above findings, no contamination of csc14 device by foreign material was confirmed.Therefore, it is very likely that complained substances were compatible with white precipitates from the salts included in the priming solution.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: CSC14 CARDIOLOGIA HEAT EXCHANGER
• Type of Device: HEAT EXCHANGER
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 16776282
• MDR Text Key: 313850072
• Report Number: 9680841-2023-00015
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 025310
• Device Lot Number: 2212210060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2023
• 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