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); Improper or Incorrect Procedure or Method (2017); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) performed pm on the system-1, system failed boot-up on battery.The total nominal available capacity (tnac) was at 16.35 amp hours (ah).The fsr checked the system data logs and found that the system had not been powered on since (b)(6) 2015.The fsr plugged in system and let charge on a/c for two hours while performing remaining pm.The tnac was not at specification of 18.00 ah.The fsr performed a/c disconnect test and the system shut down immediately.The tnac was now at 1.35ah.The fsr downloaded the system and power manager logs.On (b)(6) 2015, the fsr installed new system batteries and waited for two hours to cycle the system-1 to reset the tnac to specification of 18.00 ah and display a green light emitting diode (led) indicator on the power manager printed circuit board (pcb).The fsr completed all system tests and all passed.The unit operated to manufacturer specifications and was returned to clinical use.The fsr advised the chief perfusionist (ccp) via email regarding the proper and necessity of plugging in and turning on of the system-1 on at least monthly basis to maintain battery charge.The suspect batteries were turned to the manufacturer for further evaluation.During the laboratory evaluation, the reported complaint was confirmed as the batteries were received in a lower than typical state of discharge.They would not be expected to power the system-1 at all in the condition received.The cause of the severe depletion was not determined during evaluation.The product surveillance technician (pst) observed no anomalies upon receipt of batteries.After charging 14 hours, the batteries properly accepted charging and met minimum specifications for load support and conductance.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the system-1 powered down immediately at alternating current (a/c) disconnect.There was no patient involvement.

• 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: 5135733
• MDR Text Key: 28080998
• Report Number: 1828100-2015-00863
• 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
• Report Date: 10/07/2015

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: Other
• Device Model Number: 801763
• Device Catalogue Number: 801763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2009
• 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