MAUDE Adverse Event Report: LIVANOVA USA INC SMART PERFUSION PACKS; SMART, PERFUSION PACKS, CONNECTORS, TUBING

Catalog Number 627257503

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Event date in unknown.Sorin group italia manufactures the smart perfusion pack.The incident occurred in new hyde park, new york, united states of america.Livanova is following up with the customer to identify if the disconnection occurred during procedure or was identified at the circuit set-up.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

On (b)(6) 2022, sorin group italia received a medwatch mw5112038 that ecmo circuits are not connected at the bonded areas.Medical team have found a circuit that was supposed to have pre-bonded areas that is unconnected.There is no report of any patient injury.

Manufacturer Narrative

Livanova received a medwatch #mw5112038 stating that part of the ecmo circuit that was supposed to be pre-bonded, was unconnected.There is no report of any patient injury based on the few information provided on the mw, livanova interpreted the reported event as a disconnection from one of the 3/8¿x1/8¿ connectors in the bridge portion of the loop.Neither the involved device nor clarification on when the issue occurred, and length of time were provided.No picture was received.The dhr review confirmed the device was released conforming to product specifications.Review of the livanova complaint database identified a possible similar previous event related to another batching the complaints database another similar case on this pts pack code, but different lot number, occurred (refer to 1718850-2022-00055).According to the technical documentation of the complaint circuit item code, the involved connectors are secured using solvent.Livanova believed the event could be related to prolonged use in ecmo or to an incorrect assembly during pts manufacturing it shall be noted complaint circuit item code is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, not for ecmo.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: SMART PERFUSION PACKS
• Type of Device: SMART, PERFUSION PACKS, CONNECTORS, TUBING
• 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: 15778540
• MDR Text Key: 307800730
• Report Number: 1718850-2022-00057
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622141089
• UDI-Public: (01)00803622141089(240)627257503(17)231231(10)2135000040
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 627257503
• Device Lot Number: 2135000040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1