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 Problem Failure to Run on Battery (1466)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, when the system-1 was unplugged, it shut down.The battery icon on the central control monitor (ccm) of the system was red.The light emitting diode (led) on the front panel of the system was also red.As a result, an alternate system was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.The field service representative (fsr) verified the reported issue and the total nominal available capacity (tnac) would not go higher than 9.4.The fsr replaced the batteries and completed a verification / release test.The unit operated to manufacturer specifications and was returned to clinical use.The suspect parts were returned to the manufacturer for further evaluation.During laboratory evaluation the reported complaint was confirmed.After attempted charging, neither battery properly accept charging and both failed to meet minimum specifications for conductance.The product surveillance technician (pst) observed no anomalies upon receipt of batteries.Both batteries measured 12.5 volts direct current (vdc) upon receipt.Conductance measurements were 15 siemens (s) for the first battery and 16s for the second battery (both failing).13.2 vdc is typical for a battery having a near full charge and 375s is the minimum requirement for conductance.The pst attached device under test (dut) batteries to power manager board (pmb) platter using a lab battery cable and powered on.The pst opened the power maintenance page within the service environment to monitor battery status.No incrementing of the available capacity registers was observed for over 2 hours.No appreciable change in the batteries charge status was observed.This indicates failure of the batteries to properly accept charging.The system was switched to battery power, and ran less than 1 minute on battery backup.This corroborates the reported complaint.No further testing was performed.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: 5010352
• MDR Text Key: 24359080
• Report Number: 1828100-2015-00715
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Report Date: 09/10/2015

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: 08/31/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2009
• 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