MAUDE Adverse Event Report: LIVANOVA USA INC PERFUSION PACK; NEW COBE CARDIOPLEGIA SYSTEM PACK

Catalog Number	044053600
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There issue was identified prior to any patient involvement.Livanova usa inc manufactures the convenience pack inspire 8fs cardioflex.The incident occurred in (b)(6) united states.The involved device is available for investigation and not requested for investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova inc has received a report that, the cardioplegia set lines (1/4 and 1/8) were built incorrectly and so the lines could not be switched to go from 4:1 to 1:4.There issue was identified prior to any patient involvement.
Additional Manufacturer Narrative
Follow-up clarification with the customer clarified that the lines connected to two connectors were swapped.The dhr review highlighted that complained lot was released as conform according to specifications.No further similar complaints have been identified on this specific pts code/lot number.Livanova cannot exclude that the issue was caused by an operator error during manual pack assembly.To prevent re-occurence, the manufacturing personal is retrained.The risk is acceptable.No further action is deemed necessary.Livanova will maintain monitoring the market for similar events.H3 other text : evaluation based on additional information.
Event or Problem Description
See initial report.

• Brand Name: PERFUSION PACK
• Common Device Name: NEW COBE CARDIOPLEGIA SYSTEM PACK
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11593987
• Report Number: 1718850-2021-00027
• Device Sequence Number: 4224405
• Product Code: DTN
• UDI-Device Identifier: 00803622139642
• UDI-Public: (01)00803622139642(240)044053600(17)230131(10)2102200031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 01/31/2023
• Device Catalogue Number: 044053600
• Device Lot Number: 2102200031
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 05/09/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1