MAUDE Adverse Event Report: LIVANOVA USA INC STANDARD AND SMALL RIGID TIP SUCTION WANDS; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Model Number	SU-XXXXX
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved device has been requested for return to livanova inc for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not yet returned.
Event or Problem Description
Livanova has received a report that, the tip of the atra¿ sump sucker detached and fell into the patient's pericardium.The tip was recovered without any patient consequence.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
Seventeen (17) units of su-29602 suction cannula (the complained (1) used unit and 16 unused units belonging to the same lot still in original packaging) were returned to livanova for investigation.Visual inspection of the complained (1) cannula found that the tip was disconnected from the body of the cannula.Inspection identified that only in a portion of the bond between the tip and the inside of the tubing of the cannula was formed.No adhesive was found on the outside wall of the tube at the interface between the tip and the tube.Visual inspection of the 16 unused cannula units found the tip and the body of the units to be correctly glued.Adhesive on the wall of the tube where it interfaces with the tip could be found in all units.Pull test on the distal tip of the 16 unused units confirmed all the 16 units were complainant to product specifications.The review of the dhr did not identify any possibly related to the reported issue.No other complaint has been recorded for the claimed lot.Inspection of the complained unit confirmed the reported disconnection.Livanova investigation determined this was caused by an incorrect application of adhesive, due to operator error during manual assembly.The frequency of this type of event is low.To prevent further re-occurrence of the event, the operators involved in the assembly of this product will be re-trained on the process.Livanova will keep monitoring the market.

• Brand Name: STANDARD AND SMALL RIGID TIP SUCTION WANDS
• Common Device Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 9408780
• Report Number: 1718850-2019-00023
• Device Sequence Number: 4114547
• Product Code: DTS
• UDI-Device Identifier: 00803622105913
• UDI-Public: (01)00803622105913(240)SU-29602(17)220731(10)1919000137
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/12/2020

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: 07/31/2022
• Device Model Number: SU-XXXXX
• Device Catalogue Number: SU-29602
• Device Lot Number: 1919000137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1