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

Model Number	801764
Medical Device Problem Codes	Unintended Power Up (1162); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the manufacturer's subsidiary, the unit had been kept in the distribution warehouse in the original carton.While preparing to deliver the device to the medical facility, a noise was heard inside the carton and it was discovered that the unit had automatically powered on while the power switch was in the off position.The battery was checked and observed that it was not charging and did not switch to alternating current (ac) power.The subsidiary suspected the power manager board to be the cause of the problem and replaced the power manager board.
Event or Problem Description
Upon receipt of the device, the user reported that unit automatically powered on without charging or being connected to a power source.There was no patient involvement.
Additional Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) observed the power manager resistance across r186, r159 and r122 to fail using a multimeter to measure the values.The resistors were open which was not within specification.
Additional Manufacturer Narrative
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
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 11710073
• Report Number: 1828100-2021-00149
• Device Sequence Number: 11819863
• Product Code: DTQ
• UDI-Device Identifier: 00886799000663
• UDI-Public: (01)00886799000663(11)210122
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K172220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2021

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
• Operator of Device: Other
• Device Model Number: 801764
• Device Catalogue Number: 801764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 05/07/2021; 06/08/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/28/2021; 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1