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 Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

The fsr replaced the batteries.The unit operated to the manufacturer's specifications.The suspect parts were returned to the manufacturer for further evaluation.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the heart lung machine (hlm), the batteries would not charge above 1.54 total nominal available capacity (tnac).There was no patient involvement.

Manufacturer Narrative

Per data log analysis, the system was used on (b)(6) 2020 and then powered off.The system was left powered off until (b)(6) 2020.The battery capacity at power up was 0/16 as expected.The power manager logged the event supply voltage failure 12 with battery voltage at 9.116 volts.This disables the battery charger which explains why the batteries would not charge as reported.The batteries should be replaced since they were not properly maintained.During laboratory evaluation, the product surveillance technician received the batteries with 7.00 volts direct current (vdc) and 6.96 vdc, both batteries conductance was too low to measure.After charging the batteries reached passing readings with both batteries at 13.60 vdc but conductance measurements remained too low to get a reading.

Manufacturer Narrative

Updated block: h6.The complaint was confirmed.The fsr was able to advise the customer on how to properly charge the batteries as the customer was not aware the unit needed to be plugged in and turned on to charge.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
• MDR Report Key: 10943012
• MDR Text Key: 219552495
• Report Number: 1828100-2020-00468
• Device Sequence Number: 1
• Product Code: DTQ
• 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,Followup
• Report Date: 01/21/2021

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: Other
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 12/11/2020; 01/06/2021
• Supplement Dates FDA Received: 12/22/2020; 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1