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 Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Upon the receipt of the device, the user reported that the heart lung machine (hlm) was running on battery power even when plugged into alternating current (ac) power.There was no patient involvement.
Additional Manufacturer Narrative
Per the manufacturer's subsidiary's service technician, upon testing the hlm they noticed that the alarm for battery mode was always present even when connected to ac power, and the light emitting diode (led) on the base was flashing even when the base switch was turned off.The unit indicated it was in 'battery backup' mode.The power manager board (pmb) was tested and confirmed to be deficient.The pmb was replaced and the unit then worked normally.
Additional Manufacturer Narrative
Updated blocks: d9, h3 and h6 during laboratory analysis, the product surveillance technician (pst) installed the power manager board into lab use only (luo) testing equipment.He observed the board to have a burnt electrical smell and the battery connection sparked when connecting the board to the testing equipment.He observed that the heart lung machine (hlm) platform powered on battery power even though it was connected to alternating current (ac) power and the power switch was off.He also noted in the logs a 'can controller issued ewrn error (49)' and 'message type: 7' which was an indication a pump or module attempted to send a message on the controller area network (can) bus but could not.No anomalies were found during microscopic evaluation.The power manager board was determined to not operate to specification.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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 14251340
• Report Number: 1828100-2022-00168
• Device Sequence Number: 4302692
• Product Code: DTQ
• UDI-Device Identifier: 00886799000663
• UDI-Public: (01)00886799000663(11)220202
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2022

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 05/09/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown