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 Charging Problem (2892)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was discovered during system verification.Per the field service representative (fsr), the unit had not been turned on since 02-sept-2018.He replaced the batteries.The suspect parts were returned to the manufacturer for further evaluation.

Event Description

It was reported that during the use of the device for a non-clinical activity, the batteries were below 1.0000 amp hours (ah).There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed both batteries to charge properly and meet specifications.Upon receipt, the first battery measured 12.02 volts direct current (vdc) with a conductance reading of 385 siemens (s), passing.The second battery measured 11.99 vdc and 0s upon receipt.After charging, the batteries measured 13.48 vdc, 513s and 13.42 vdc and 515s, both passing.

• 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: 8125418
• MDR Text Key: 129077243
• Report Number: 1828100-2018-00615
• 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: 01/16/2019

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: 11/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/06/2018; 01/08/2019
• Supplement Dates FDA Received: 12/17/2018; 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1828100-03/13/12-004-C
• Patient Sequence Number: 1