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

Model Number 5160-0000

Device Problem Partial Blockage (1065)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2019

Event Type  malfunction  

Event Description

It was reported that a clot was noted in the oxygenator during support.The oxygenator was exchanged once the patient's va ecmo was removed.This was the second oxygenator used during support of this patient, a clot was observed in the first oxygenator leading to replacement reported in mfg report number # 2531527-2019-00052.The event was observed post tandem heart insertion while the patient was on support.No adverse events were reported for the patient.The serial number of the oxygenator is unknown to date.No further relevant information has been received to date.

• Brand Name: TANDEMLUNG OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: njemile crawley ; 620 alpha drive; pittsburgh, PA 15238 ; 2812287200
• MDR Report Key: 9255833
• MDR Text Key: 178625049
• Report Number: 2531527-2019-00053
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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 Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2019
• 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
• Patient Age: 33 YR