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 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.The fsr installed the suspect batteries in (b)(6) 2015.The fsr called the ccp explained what happened.The ccp mentioned that they haven't been using that system that much and have not been rotating it in the schedule of surgery.The fsr looked into data log files and saw that the system had not been powered on from (b)(6) 2015 until (b)(6) 2015.The fsr measured the battery voltage and each battery measured 6 volts direct current (vdc).The fsr ordered replacement batteries and installed the new batteries successfully.The unit operated to manufacturer specifications and was returned to clinical use.The suspect batteries were returned to the manufacturer for further evaluation.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, he had the system-1 unplugged, attempted to power on the system and nothing happened.The system did not turn on.The light emitting diode (led) light on the front panel of the system-1 was green.The fsr plugged the system power cord into an alternating current (a/c) wall outlet and the system turned on successfully.When the fsr unplugged the system-1 it powered down immediately.There was no patient involvement.

Manufacturer Narrative

(b)(4) -maintenance does not comply to manufacturers recommendations.Corrected (b)(4) should have been unchecked.The reported complaint was confirmed.During the laboratory evaluation, the product surveillance technician (pst) observed the batteries were received in a severely depleted condition.After charging 14 hours, both batteries met the specifications for the characteristics evaluated.The voltage at each of the batteries was 13.2 vdc (typical).Conductance values were also typical at 534 siemens(s) and 537s.This indicates that both batteries properly accepted charging.13.2 vdc is typical for a battery having a full charge.375s is the minimum requirement for conductance.The batteries held the load for approximately 67 minutes.Minimum requirement with the stated load is 50 minutes.No anomalies observed upon receipt of batteries.The batteries were not being properly maintained, the customer had the unit plugged in but not turned on which would not charge the batteries.The fsr reminded the perfusionist about proper maintenance.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: 4963674
• MDR Text Key: 23403276
• Report Number: 1828100-2015-00666
• 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

• 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: 08/03/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2006
• 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