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 Nonstandard Device (1420); Failure to Run on Battery (1466)

Patient Problem No Patient Involvement (2645)

Event Date 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The fsr installed the suspect batteries in (b)(6) 2015.Per fsr, the data logs confirmed that the system-1 has not been powered since (b)(6) 2015.The fsr installed new batteries before attempting any battery tests.Waited two hours for power manager to reset and completed inspection.The unit operated to manufacturer specifications and was returned to clinical use.The suspect batteries were returned to the manufacturer for further evaluation.During laboratory evaluation, the product surveillance technician (pst) duplicated the reported issue.The batteries were received in a completely discharged state.The batteries properly accepted recharging and passed all subsequent testing.There were no anomalies observed upon receipt of batteries.Batteries both measured 11.0 volts direct current (vdc) upon receipt.This is too low to support the system-1 on battery power for any length of time and corroborates the reported complaint.A 11.4 vdc is a typical level for a completely discharged battery.The pst attached device under test (dut) batteries to the test platter using a laboratory battery cable and powered on.The pst opened the power maintenance page within the service environment to monitor battery status.Batteries were allowed to charge for 15 hours (recommended recharge time from full depletion is 13 hours.) total nominal available capacity (tnac) is 18 amp hours (ah) (indicates full charge.) the status light emitting diode (led) was green (typical).After charging, the voltage readings of the batteries were: 13.2 and 13.0 vdc.This indicates that both batteries properly accept charging.A 13.2 vdc is typical for a battery having a full charge.Conductance measurements were 513siemens(s) and 503s respectively.375s is the minimum requirement for conductance.A load test was then conducted using the system-1 load simulator.The batteries passed the load test by supporting the load for 63 minutes (50 minutes is the required minimum) a full recharge of the dut batteries was performed following passage of the load test.Final battery readings indicate good battery health at 13.1 vdc / 527s and 13.1 / 518s respectively.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the system-1 base would not boot on battery.There was no patient involvement.

Manufacturer Narrative

(b)(4) maintenance does not comply to manufacturers recommendations.The reported complaint was confirmed.The customer is aware of proper battery maintenance.They just forgot to perform it for this unit.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: 4964718
• MDR Text Key: 23439182
• Report Number: 1828100-2015-00670
• 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
• Remedial Action: Recall
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• 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: 07/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2008
• 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