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

Model Number 801763

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) identified the reported issue.He replaced the power supply.The unit operated to the manufacturer's specifications.The suspect device was sent back to the manufacturer for further evaluation.During laboratory analysis, the product surveillance technician (pst) was able to duplicate the complaint.The power supply failed three times when tested in accordance with the power supply test procedure.The power supply fan was not functioning and the output voltage was not reading within the expected specifications.

Event Description

The field service representative (fsr) reported that during installation of the new heart lung machine (hlm), the power supply failed.There was no patient involvement.

Manufacturer Narrative

Updated block: h6.The reported complaint was confirmed.During laboratory analysis, the product surveillance technician observed the voltage readings of the power supply to be out of specification.The voltage readings were 0.116 and 0.113 volts direct current (vdc), specification is 24.5 vdc +/- 5%.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; an arbor MI 48103
• MDR Report Key: 10836432
• MDR Text Key: 216132753
• Report Number: 1828100-2020-00441
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000656
• UDI-Public: (01)00886799000656(11)200916
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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: Other
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/13/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1