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 Failure to Charge (1085)

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

Event Type  malfunction  

Event Description

It was reported that the batteries on the heart lung machine (hlm) would not charge.No other details regarding the nature of the event were provided.

Manufacturer Narrative

The field service representative (fsr) verified the heart lung machine (hlm) displayed a two year battery service message.He replaced the batteries.The unit operated to the manufacturer's specifications.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician observed the batteries to be received at 13.08 volts direct current (vdc) and 487 siemens (s) for the first battery and 13.08 vdc and 486 s for the second battery, both passing.The batteries were fully charged and then attached to a load simulator.The batteries lasted for 76 minutes, 52 minutes is passing.

Manufacturer Narrative

The reported complaint could not be confirmed.Per data log analysis, the complaint was called in on (b)(6) 2019, the date the problem occurred (battery not charging) was not provided.The logs were exported on (b)(6) 2019.The system log goes back to (b)(6) 2019 and did not even cover the date the complaint was called in.The power manager log covers a much longer time frame.According to the power manager log, the system was powered up on (b)(6) 2019.The system was left powered on until the log was exported on (b)(6) 2019.During that time the system was on battery backup a total of five times without losing power (battery backup was functional).There was no way to tell what the battery capacity was during that time from the power manager log.The system log showed the battery capacity was full (15/16) from (b)(6) 2019 to (b)(6) 2019.It was possible the power manager detected the battery capacity was low when battery backup was tested during the long power up time.This may cause the light emitting diode (led) to be red, but since the system log does not cover that time period there is no way to tell from the log.There is also no way to tell if battery charging is functional since battery backup was never tested in the system log.The system did not detect a problem with the battery charging circuit.The complaint cannot be confirmed from the log.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: 9508695
• MDR Text Key: 199129077
• Report Number: 1828100-2019-00687
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 00886799000656
• UDI-Public: (01)00886799000656(11)180123
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/23/2020

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: Health Professional
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/22/2019
• Supplement Dates Manufacturer Received: 02/11/2020; 03/09/2020; 04/13/2020
• Supplement Dates FDA Received: 03/02/2020; 03/30/2020; 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1