MAUDE Adverse Event Report: LIVANOVA USA INC COBE SMARXT TUBING AND CONNECTORS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number	627374402
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova usa inc manufactures the convenience pack adult pump and table pack montfiore med ctr (b)(6).The incident occurred in (b)(6), united states.The involved device is not available for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.On 08/apr/2022, livanova submitted the medwatch (livanova complaint ref 2022-01587) and we have received the 1st and 2nd ack (b)(4).However, after 2 days since submission, no 3rdack had not been received yet.On 11/apr/2022, livanova contacted cesub help desk (b)(4) to request information on submission result.On 13/apr/2022, cesub help desk responded that the submission with the core id (b)(4) could not be processed as there seems to be an issue: xml is invalid against schema.Please check your submission for any errors, repackage it properly and resubmit it.On 14/apr/2022, livanova is resubmitting the medwatch.
Event or Problem Description
Livanova usa inc has been informed that, during priming of the circuit, the medical team identified that white and yellow clamps of the cardioplegia circuit were swapped with the respect to the technical drawing.There is no patient involvement.
Additional Manufacturer Narrative
At the submission of the case, the customer provides a picture confirming the reported mis-assembly.The dhr review highlighted that claimed lot was released as conforming to product specifications.A review of the livanova complaints database revealed that a previous similar event occurred on this circuit item code.Based on the above, livanova believes the most likely root cause of the reported event was a manufacturing operator error during the assembly phase of this circuit.The personnel will be involved in a dedicated training meeting.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: COBE SMARXT TUBING AND CONNECTORS
• 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: 14110070
• Report Number: 1718850-2022-00028
• Device Sequence Number: 20152670
• Product Code: DWE
• UDI-Device Identifier: 00803622137440
• UDI-Public: (01)00803622137440(240)627374402(17)240229(10)2203500080
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/06/2022

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: 02/29/2024
• Device Catalogue Number: 627374402
• Device Lot Number: 2203500080
• Was Device Available for Evaluation?: No
• 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: 03/10/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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