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 801763

Device Problems Failure to Run on Battery (1466); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per manufacturer technical support (ts): the biomed is a manufacturer trained biomed, and they do their own pm¿s.The batteries were replaced in december 2015, but not with a manufacturer provided battery.The battery voltage was 21 volts (v) when disconnected from the power manager (way too low).This system is usually in storage and only checked every six months for a pm.Ts explained the system should be powered up to allow the batteries to charge at least every 30 days.The biomed will replace the batteries and do release testing.Per follow-up with the biomed (b)(6) 2016: when the biomed unplugged the unit, there was "zero" minutes displayed on the central control monitor (ccm) battery icon, there was no time lag between the aps1 being unplugged and shutdown, on the front panel of the aps1 there was no power light emitting diode (led) light illuminated, the biomed did not see or hear a warning before the system shut down, there is no battery maintenance schedule/procedure, the biomed does not fully charge your battery at least once a month, they do not fully discharging the batteries, and he maintains the charge in the batteries by keeping the aps1 plugged in.No part will be returned to the manufacture for evaluation.

Event Description

The user facility's biomedical engineer (biomed) reported that during preventive maintenance (pm) of the device, the perfusion system (aps1) would not power up or run on battery back-up.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: 5764526
• MDR Text Key: 48680557
• Report Number: 1828100-2016-00478
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

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: Health Professional
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-03/13/12-004-C
• Patient Sequence Number: 1