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 802018

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) ordered a replacement sensor for the customer.The reported complaint was confirmed during laboratory evaluation.The product surveillance technician (pst)connected the flowmeter module to a system 1 simulator.The light emitting diode (led) indicator on the module did not illuminate and the module was not able to be assigned to a perfusion screen.The pst opened the module and temporarily replaced the generic board with a lab-tested generic board.With a lab-tested generic board installed, the flowmeter module¿s led indicator illuminated and the module was able to be assigned to a perfusion screen.The pst measured the 5 volt supply on the generic board and it was present.During visual inspection nothing was observed that would cause failure.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

Upon receipt of the device, the user reported that the flow sensor would not assign.There was no patient involvement.

Manufacturer Narrative

The field service representative (fsr) removed the suspect flow module and installed a new flow module.The fsr assigned the module and completed all testing.The unit operated to manufacturer specifications and was returned to clinical use.During further laboratory evaluation, the issue was isolated to fatigued solder joints on p5 of the generic board causing insufficient electrical continuity.These solder joints became fatigued because an improper sized stand-off was used.The smaller stand-off between the generic and application board caused flexing on the generic board when it was tightened down, fatiguing the solder joints on the connector.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: 4953106
• MDR Text Key: 23264270
• Report Number: 1828100-2015-00645
• 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: Other
• Report Date: 09/18/2015

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: 802018
• Device Catalogue Number: 802018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2014
• 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