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

Model Number 5160-0000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Cardiacassist inc manufactures the tandemlung oxygenator.The incident occurred in (b)(6).Investigation is in progress.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 tandemlung oxygenator had a small leak.The blood appeared to be leaking from the blood path to the gas cap between the potting and the housing.This occurred at the initiation of support.The device was changed and support continued without issue.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10: a review of the dhr could not identify any deviations or nonconformities relevant to the issue.Tandemlung oxygenator was returned to the manufacturer site for investigation.The reported leak was not reproducible during investigation.This may be due to the residual blood clotting/plugging the leak path.However, blood residues were identified at the level of the leaking part in the potting region.During tests, another leak was identified at the level of the blood outlet connector.However, this issue was not complained by the customer thus it is reasonable to assume that it originated by damage occurred during device shipping for return.A complaints database review did not identify similar events.An isolated manufacturing issue cannot be ruled out.

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh 15238
• MDR Report Key: 10579173
• MDR Text Key: 208308384
• Report Number: 2531527-2020-00030
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K153295
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1