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 801764

Device Problem Failure to Run on Battery (1466)

Patient Problem No Patient Involvement (2645)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the subsidiary distributor, while troubleshooting he found the power manager board was defective and needs replacement.Per follow-up with the subsidiary distributor on 29-sep-2015, the power light emitting diode (led) light on the front panel of the system-1 was yellow.The suspect part will be returned to the manufacturer for further evaluation.

Event Description

The subsidiary user facility reported that during routine testing of the device at the service center, the system-1 did not switch over to battery from main power.When the main supply failed, the system does not change over to battery which was fully charged.There was no patient involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

The reported issue was confirmed.During the laboratory evaluation, the product surveillance technician (pst) observed two open resistors r122 and r159 of the power manager printed circuit board (pcb).The pst observed no anomalies upon non-magnified visual inspection of power manager pcb and generic pcb.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: 5144711
• MDR Text Key: 28266805
• Report Number: 1828100-2015-00875
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 12/04/2015

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: 801764
• Device Catalogue Number: 801764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/04/2015; 12/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2002
• 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