MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 145955

Device Problems Failure to Power Up (1476); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The fsr plugged the system in and rebooted it on alternating current (a/c) power successfully.When the fsr went to the service screen, the battery status showed <0.1 amp hours (ah) and the power manager status lamp was red.After charging for about ten minutes, the battery status screen showed 18.00ah and the power manager lamp was green.The fsr unplugged the system and it ran on battery power for about five minutes and shut off.The fsr replaced the defective batteries and downloaded the data logs for this system.He tested the battery functions satisfactory.The unit operated to manufacturer specifications and was returned to clinical use.The suspect batteries were returned to the manufacturer for further evaluation.During the laboratory evaluation, the reported issue was duplicated.One battery was not accepting a charge.The batteries measured 13.0 volts direct current (vdc) and 11.2 vdc upon receipt.Conductance measurements were 513 siemens(s) on the first battery and not available for the second, due to the low voltage.(the meter requires approximately 11.8 vdc to get a reading).The product surveillance technician (pst) connected the batteries to a power manager test platter with the system-1 (aps1) load simulator attached.The pst attempted to power up the system on battery but failed.The system shut down as there was not enough power to complete the ccm boot-up.This duplicates the reported complaint.A/c power was restored and charging begun.Within one hour the charger was found to be off, indicating charge completion, however the second battery still measured low at 12.1 vdc and 66 s (failing).This indicates the second battery is not properly charging and corroborates the reported complaint.The low conductance reading further indicates internal battery degradation.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, he installed new batteries that were received by the customer on 20-jan-2016 and powered up the system on battery per procedure.The system did not complete the boot-up, it did not make it to the splash screen on the central control monitor (ccm).This is considered an "out of box" failure.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.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5507176
• MDR Text Key: 40798209
• Report Number: 1828100-2016-00187
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

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: 145955
• Device Catalogue Number: 145955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2016
• Initial Date FDA Received: 03/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1