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 Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) replaced the batteries.The unit operated to manufacturer's specifications.

Event Description

It was reported that a 'service battery' message was displayed on the heart lung machine (hlm).No other details regarding the nature of this event were provided.

Manufacturer Narrative

The reported complaint was confirmed.Per data log analysis, the system was used on (b)(6) 2019 and the battery was full.The system was not powered up again until (b)(6) 2019 and the battery capacity was automatically adjusted down to 6/16 based on storage time.The system was only powered for six minutes so the batteries were not recharged.The next power up was on (b)(6) 2019 and the battery capacity was automatically adjusted down to 2/16 based on storage time.The system was only powered for a few minutes again, not allowing the batteries to charge.The next power up was on (b)(6) 2020 on battery power and the system quickly does a depleted battery shutdown.The next power up on (b)(6) 2020 was on alternate current (ac) power but a supply voltage failure occurred (12) which was 'id_battery_circuit_failure' vbat = 21.282 volts (v).This will disable the battery charger and cause a 'battery cannot be charged' message in the perfusion screen.The system was powered down again and not powered up until (b)(6) 2020.Another supply voltage failure occurs (12) which was 'id_battery_circuit_failure' vbat = 9.732v.There was no indication of a 'service battery message' on (b)(6) 2020 as reported but it is likely the messages were from (b)(6) 2020 and (b)(6) 2020.The log did confirm a battery message occurred.During laboratory analysis, the product surveillance technician (pst) observed the batteries to arrive not meeting the minimum voltage specifications.However, the batteries were able to be properly charged and he observed the power manager test platter to shut down after 70 minutes of discharge while the specification is 52 minutes.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: 10032529
• MDR Text Key: 190134007
• Report Number: 1828100-2020-00185
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1