MAUDE Adverse Event Report: LIVANOVA USA INC CHILDRENS HSP PITTSBURGH PA 2; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	627356301
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient was not involved.Sorin group italia manufactures the perfusion pack.The incident occurred in united states.The involved device has been requested for return for investigation.Through follow up with the customer, the perfusionist confirmed the occlusions were checked carefully when the replacement disposable was loaded and the pump has functioned properly since.It cannot be confirmed if the pump was occluded when the issue occurred, pump is currently working correctly if any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa received a report that, during priming, the segment of the tubing inside the pump raceway split open and leaked.There was no patient involvement.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
No pictures were available.The tubing was requested for investigation.Visual inspection confirmed the tubing split, the length of the split was approximately 1/2", on the 22" portion of line 4.Dimensional analysis of the tubing taken for two un-split samples directly on either side of the split tubing with the help of an optical comparator confirmed the complained tubing was within the specification.The tubing is bought from a suppliers and livanova internal statistical sampling is done.No other similar complaint has been recorded for the same lot or pts pack code.Therefore, it can be considerated as an isolated case.Based on the information available an isolated failure in the manufacturing process cannot be ruled out.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: CHILDRENS HSP PITTSBURGH PA 2
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17002166
• Report Number: 1718850-2023-00029
• Device Sequence Number: 6286123
• Product Code: DWE
• UDI-Device Identifier: 00803622131295
• UDI-Public: (01)00803622131295(240)627356301(17)250404(10)2309500051(11)230405
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2024
• Device Model Number: 627356301
• Device Lot Number: 2309500051
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown