MAUDE Adverse Event Report: LIVANOVA USA INC SUCTION SUMP, WITH ¼¿ CONNECTOR; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Model Number	SU-XXXXX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa received a report that, following an event of tip disconnection, the medical team manually tested two atrasump item su-29602 from the shelf and noted that were able to pull the tips off the cannulae without too much manual force.There was no patient involvement.
Additional Manufacturer Narrative
There was no patient involvement.The complained device has been received at livanova for investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa received a report that, following an event of tip disconnection, the medical team manually tested two suctionsump item su-20602 from the shelf and noted that were able to pull the tips off the cannulae without too much manual force.There was no patient involvement.
Additional Manufacturer Narrative
Three units from three different complaints all related to the same failure (sump tip disconnection) were investigated altogether.The contaminated unit was found disconnected, the tip and the silicon body of the cannula were separated.The uncontaminated units were found with the tips still in place.However, pull test on the units confirmed the tips could disconnect easily.Livanova investigation confirmed the on all three returned samples the disconnection between the spring inner tubing and the connector.The dhr review highlighted of the complained lot confirmed the device was released conforming to product specifications.The review of the livanova complaint database identified other similar events from different customers and related to different cannula lots.However, similar events involved atra sump (catalogue item code #su-29602) and no other event involved the suction sump (catalogue item code #su-20xxx).Thus, this case is isolated.Based on above, it cannot be ruled out that the root cause of the tip detachment is related to a manufacturing deviation during the assembly phase.The risk is in the acceptable region.To prevent reoccurrence, the manufacturing personnel will be involved in a dedicated training meeting warning of customer complaint.Livanova maintains and document periodic customer events monitoring process in order to evaluate actions for products improvement.Livanova will keep monitoring the market.During investigation, it was assessed that the items and corresponding lots provided in the initial reports of the medwatch reports 1718850-2022-00044 (corresponding to livanova complaint ref (b)(4)), 1718850-2022-00045 (corresponding to livanova complaint ref (b)(4) and 1718850-2022-00046 (corresponding to livanova complaint ref (b)(4), present report) were swapped.Corrected information is being provided in the present follow-up report.Therefore, b5.Describe event or problem, d1 brand name, d2 common device name; d4 catalog number, lot number, expiration date, unique identifier (udi) number and h4.Device manufacturer date were updated accordingly.

• Brand Name: SUCTION SUMP, WITH ¼¿ CONNECTOR
• Common Device Name: SUCKER, CARDIOTOMY RETURN, 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: 15011648
• Report Number: 1718850-2022-00046
• Device Sequence Number: 12450851
• Product Code: DTS
• UDI-Device Identifier: 00803622105876
• UDI-Public: (01)00803622105876(240)SU-20602(17)250331(10)2208800092
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 10/13/2022

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: 03/31/2025
• Device Model Number: SU-XXXXX
• Device Catalogue Number: SU-20602
• Device Lot Number: 2208800092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• 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: 06/15/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2022
• 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