MAUDE Adverse Event Report: CARDIACASSIST INC. TANDEMLUNG OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 5160-0000

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Cardiacassist inc.Manufactures the tandemlung oxygenator.The incident occurred in (b)(6).Through follow-up communication livanova learned stated the device was never dropped or aggressive handled and no instruments were used to tap the housing during priming nor were any aggressive cleaning agents used.Reportedly, the pump and oxygenator were in the holster in the same spot they had been since the start of the case.Tandemlung oxygenator was returned to the manufacturer site for investigation.Results confirmed the cracks along the housing of the oxygenator.Additionally, the gas outlet cap appeared partially separated from the housing.After three (3) days of tests, the leakage could be reproduced at the level of the cracks.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that on (b)(6), a patient was placed on va ecls support with a tandemheart pump and tandemlung oxygenator without issue.The pump and oxygenator were secured in the tandemlife holster throughout support.On day 4 of support a crack and leak from the oxygenator housing was noticed.The oxygenator was replaced, and support continued without issue.There was no report of patient injury.

• Brand Name: TANDEMLUNG OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, PA 80004
• MDR Report Key: 10199503
• MDR Text Key: 197286410
• Report Number: 2531527-2020-00020
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5160-0000
• Device Catalogue Number: 5160-0000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• 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