MAUDE Adverse Event Report: LIVANOVA USA INC MALL PERIC SUMP 1/4 CONN; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Model Number	SU-20802
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa received a report of a malfunction with a livanova suction tip catheter sumps.No further information was provided.
Additional Manufacturer Narrative
A.1.-a.5.Patient involvement or information were not provided.H.10.Livanova usa manufactures the sumps, flexible and malleable sump with wire-wound tip.The incident occurred in united states.Livanova is following up with the customer to obtain further information.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Despite requested, no additional information was received on the present event.Considering that, the week before receiving information on the present event, livanova was made aware by the same customer of an event related to the same cannula item code (but different lot), it cannot be excluded that the reported malfunction is related to the same issue of the previous event (reported under mfr report number 1718850-2023-00028).That event alleged to an off-label use.In the instruction for use of the suction sump su-20x02, there is the following warning: ¿do not place the suction sump through the leaflets of a valve as damage to the valve may occur¿.To prevent reoccurrence, livanova has concluded to enhance the visibility of the above warning by repeating the warning also in a label applied to the peel pouch/primary sterile barrier.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See intial report.

• Brand Name: MALL PERIC SUMP 1/4 CONN
• 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 DEUTSCHLAND GMBH; lindberghstrasse 25; arvada CO 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17009352
• Report Number: 1718850-2023-00030
• Device Sequence Number: 15342162
• Product Code: DTS
• UDI-Device Identifier: 00803622105883
• UDI-Public: (01)00803622105883(240)SU-20802(17)230731(10)2019500125
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/15/2023

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: 07/31/2023
• Device Model Number: SU-20802
• Device Lot Number: 2019500125
• Was Device Available for Evaluation?: Yes
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2020
• 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