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

Model Number 5160-0000

Device Problem Improper Flow or Infusion (2954)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

Cardiacassist.Inc manufactures the tandemlung oxygenator.The incident occurred in (b)(6).Through follow-up communication livanova learned that the o2 saturation never increased satisfactorily since the support was started.The oxygenator was not made available for investigation thus a malfunction cannot be excluded.However, based on the fact that o2 saturation values never reached the desired level, it is reasonable to think that the oxygenation level required by the patient was not adequate to the type of oxygenator used for the support (maximum performance of the oxygenator not satisfying the needed oxygenation).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 the patient o2 saturation could not increase and blood color did not change during support with tandem lung oxygenator.The user replaced the circuit with another and immediate blood color change and o2 saturation value increase could be observed.There was no 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 ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 11573839
• MDR Text Key: 243147019
• Report Number: 2531527-2021-00013
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: 00603594
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/26/2021
• 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