MAUDE Adverse Event Report: LIVANOVA INC. USA CARDIOPLEGIA PACKS, PERFUSION TUBING SET, PERFUSION TUBING, TUBING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	627285601
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H.10.Livanova usa inc manufactures the convenience pack.The incident occurred in cleveland, ohio.Livanova initiated an investigation.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 inc.Received a report that colored (white and red) clamps in the cardioplegia line in 1 unit were reversed.In particular, they were flipped and placed on the wrong line.It was still able to be used for surgery.There was no patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: the dhr review highlighted that the complained lot was released conforming to product specifications.No other similar events were reported on this lot number.Based on the above, the most likely root cause of the reported misassembly was due to an isolated manufacturing operator error during the assembly phase of this circuit.To prevent re-occurrence, the manufacturing personnel has been involved in a dedicated training meeting to discuss the specific event.

• Brand Name: CARDIOPLEGIA PACKS, PERFUSION TUBING SET, PERFUSION TUBING, TUBING
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA INC. USA; 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: 18481983
• Report Number: 1718850-2024-00022
• Device Sequence Number: 11443824
• Product Code: DWE
• UDI-Device Identifier: 00803622119880
• UDI-Public: (01)00803622119880(240)627285601(17)240831(10)2223700044
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K920312
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2024

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 Model Number: 627285601
• Device Lot Number: 2223700044
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2022
• 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