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

Catalog Number 044010903

Device Problem Disconnection (1171)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

A.1.A.5.Patient information were not provided.D.4.The lot number of the smart perfusion pack is uknown.The expiry date and the udi are also unknown.D.4.The lot number of the smart perfusion pack is uknown.The manufacturind date is also unknown.H.10.Livanova manufactures the smart perfusion pack.The incident occurred in usa.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova usa inc has received a report that, during support, a line separated from the cardioplegia heat exchanger coil.There is no report of any patient injury.

• Brand Name: SMART, PERFUSION PACKS, CONNECTORS, TUBING
• Type of Device: TUBING
• Manufacturer (Section D): LIVANOVA USA; 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: 18992212
• MDR Text Key: 339102328
• Report Number: 1718850-2024-00026
• Device Sequence Number: 1
• Product Code: DWE
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 044010903
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1