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

Catalog Number 044053600

Device Problem Misassembled (1398)

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

Event Date 03/04/2021

Event Type  malfunction  

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 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.

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 Description

See initial report.

• Brand Name: PERFUSION PACK
• Type of Device: NEW COBE CARDIOPLEGIA SYSTEM PACK
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11593987
• MDR Text Key: 251214126
• Report Number: 1718850-2021-00027
• Device Sequence Number: 1
• Product Code: DTN
• UDI-Device Identifier: 00803622139642
• UDI-Public: (01)00803622139642(240)044053600(17)230131(10)2102200031
• Combination Product (y/n): N
• PMA/PMN Number: K920312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1