MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 816572

Device Problems Bent (1059); Device Inoperable (1663); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation is in progress, but not yet concluded.As per perfusionist, they attempted to disconnect and reconnect the unit but it did not resolve the issue.Per field service representative (fsr), the user facility's biomedical technician (biomed) discovered that the centrifugal cable assembly was disconnected and the male end of the cable assembly had a bent pin to the point that it was touching other pins.The biomed straightened the pin and attempted to plug it back into the network interface card (nic) board but was unsuccessful.The fsr replaced the cable assembly but was unable to attach the cable to the nic board as there were no stand-offs located at nic board connection on the left side.The fsr removed the stand-offs from right side and installed them on the left side.He then installed the cable assembly, plugged it into centrifugal module and the unit powered up.The unit operated to the manufacturer¿s specifications.The cable assembly was returned to the manufacturer for further evaluation.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the centrifugal control module on the system was not turning on.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) observed pin damage, but the cable functioned normally with no problems.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

The reported complaint was confirmed.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: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6680875
• MDR Text Key: 78970510
• Report Number: 1828100-2017-00290
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2017

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: 816572
• Device Catalogue Number: 816572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 07/12/2017; 08/30/2017
• Supplement Dates FDA Received: 08/04/2017; 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2013
• 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