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 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

This issue was discovered by the field service representative (fsr) during a unit upgrade.As per fsr, the user facility only uses this unit for training purposes so they do not charge it.The unit is also turned on only once per month.The fsr replaced the batteries.The unit operated to the manufacturers specification.The suspect part was returned to the manufacturer for further evaluation.

Event Description

It was reported that during use of the device for a non-clinical activity, the batteries of the heart-lung machine (hlm) were completely dead.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory evaluation, the product surveillance technician (pst) observed both batteries to fail.The first battery had a voltage measurement of 0.450 volts direct current (vdc) and a reading of 0 siemens (s).After charging it measured 12.13 vdc and 71 s, which is failing.The second battery had a voltage measurement of 0.391 vdc and 9 s reading, the minimum conductance reading is 375 s.After charging, the second battery was reading 12.02 vdc and 146 s.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: 8078915
• MDR Text Key: 128053381
• Report Number: 1828100-2018-00595
• 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
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• 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: 11/05/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1