MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS; HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES

Model Number	S351-70
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information were not provided.Sorin group (b)(4) manufactures the hand-held intracardiac suckers.The incident occurred in (b)(6).The complained sucker was returned to sorin group (b)(4) and sent to decontamination as per livanova procedure on blood contaminated goods.Visual inspection of the sucker after decontamination found the tip of the sucker disconnected form the body of the device.Blood traces were found along the entire surface of the sucker.No other obvious defect was visible.To verify the interference between the tip and the body of the sucker, the tip was re-assembled and manually pull tested: minimal pull force enabled the disconnection of the tip from the body of sucker.Dhr review did not identify any issue relevant to the claimed problem: the device was released conforming to product specification.Livanova has not been informed of any other similar event related to the complained batch thus suggesting an isolated event.Based on livanova investigation, the disconnection is ascribable to inadequate application of bonding solvent during the assembly of the sucker.To prevent reoccurrence, the manufacturing operators will be trained on correct assembly procedure and sensitized on this type of event.As this appears as an isolated case of human error with low frequency (improbable) and the risk associated it is in the acceptable region, no other corrective action will be undertaken.Livanova will keep monitoring the market.
Event or Problem Description
On august 26th, 2019, sorin group (b)(4) has been informed that tip of the s351-70 sucker dissolves during procedure.There was no report of any patient injury.Follow up attempts to clarify the failure with the customer were in successful and the case was evaluated as not reportable.On november 25th, 2019, during visual inspection of the returned s351-70 sucker, it was found that the tip has detached from the rest of the sucker.Based on this evidence the case has been evaluated as reportable and a 30days report is to be submitted.

• Brand Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Common Device Name: HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 9503498
• Report Number: 9680841-2019-00042
• Device Sequence Number: 13560508
• Product Code: DTS
• UDI-Device Identifier: 08033178004466
• UDI-Public: (01)08033178004466(17)220107(10)1901080013
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K900339
• 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
• Report Date (Section B): 12/20/2019

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: 01/22/2022
• Device Model Number: S351-70
• Device Catalogue Number: S351-70
• Device Lot Number: 1901080013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1