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

Model Number 5160-0000

Device Problem Obstruction of Flow (2423)

Patient Problem Hypoxia (1918)

Event Date 08/09/2019

Event Type  Injury  

Event Description

Livanova received report of worsening thrombus noted at the level of tandelung oxygenator.The device was exchanged without complication.Post device exchange, initiation of full vent support was required and patient became hypoxic with hd compromise.In addition, chattering and decreased flow were noted.Pump speed was decreased and fluid bolus was given.No adverse outcome of the patient was reported.

Manufacturer Narrative

Cardiacassist inc.Manufactures the tandemlung oxygenator.The incident occurred in (b)(6).A medical assessment on the reported event has been conducted.The outcome of the assessment revealed that most likely the patient was ecmo dependent and is typical to have hypoxia episode in case of oxygenator replacement.In addition, as per medical assessment, chattering may have been due to the cannula and this behavior can be expected and can be anticipated.Moreover, in case of clotting formation, the entire circuit should have been replaced and not the oxygenator only.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: the serial number of the device was not provided, thus dhr review could not be performed.The event occurred on ards patient with 175 act value on day before the event occurred.As per tandemlung oxygenator's instruction for use the effect of anticoagulants (e.G.Heparin) is required to be checked at regular intervals by measuring the activated clotting time (act) and the act should not fall below 450 sec.Taking into account the available information, it is unlikely that the device had malfunctioned and the reported event is most likely associated to patient/procedure factors such as anticoagulation theraphy.

Event Description

See initial report.

• 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 ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 12878114
• MDR Text Key: 281275261
• Report Number: 2531527-2021-00047
• 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,Followup
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/28/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other