MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 164267

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2022

Event Type  malfunction  

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the centrifugal motor cord was damaged with exposed wires.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The field service representative (fsr) confirmed the reported complaint.She replaced the centrifugal motor.Verification/release testing was performed.The unit operated to the manufacturer's specifications.During laboratory evaluation, the product surveillance technician (pst) observed the motor cord to be damaged.The centrifugal motor was attached to laboratory use only (luo) testing equipment and was found to function as intended.The cord was agitated and found not to affect the pump performance.

Event Description

Per clinical review: on 27apr2022, the team experienced a problem with their heart lung machine.While priming, it was discovered that the centrifugal motor drive cable was damaged, with exposed wires.The centrifugal motor unit was replaced.There was no delay and no blood loss, and the surgery was completed successfully.

Manufacturer Narrative

Updated blocks: b5 and h6 the reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 14462345
• MDR Text Key: 292612045
• Report Number: 1828100-2022-00205
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 164267
• Device Catalogue Number: 164267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1