MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; CENTRIFUGAL SYSTEM

Model Number 816572

Device Problems Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2014

Event Type  malfunction  

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass procedure, the perfusionist (ccp) stated they had experienced "some type of pump disconnect" message prior to the morning surgery.At that time (approximately 9:30am), the ccp removed the power/communication cable and reinserted, and all was good through the rest of the morning case.The device was not changed out.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the patient.

Manufacturer Narrative

The software data logs were received by the manufacturer on 09/01/2014.The reported complaint was confirmed by the field service representative (fsr).The fsr worked with perfusionist (ccp) to troubleshoot the device.The fsr suggested that the cable connector on the "motor to the centrifugal controller" should be checked.The ccp was able to turn the connector lock ring about five full turns before it was snug.We then removed the connector to show that a "connect motor" message was displayed on the centrifugal controller.The fsr determined it was user error as the drive motor was not properly connected to the centrifugal control unit.The fsr later performed preventative maintenance (pm) on the unit and it operated to manufacturer specifications and was returned to clinical use.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4202541
• MDR Text Key: 4962695
• Report Number: 1828100-2014-00766
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2014

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2014
• Initial Date FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• 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