MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS CENTRIFUGAL SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM

Model Number 164267

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer wants motor checked out.Per e-mail from the field service representative (fsr) on 27-jun-2016: he spoke with the user facility¿s biomedical engineer (biomed) at the user facility.The biomed is a manufacturer trained biomed for system-1.He is going to follow up with the ccp to see if a repair is needed.Prior to the fsr's call, the biomed was not aware of an issue regarding a centrifugal drive motor.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the pump head in the pack became uncoupled during set-up.The user changed out the head first and still decoupling.They then changed out centrifugal drive motor and it seemed to work.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The user facility¿s biomedical engineer (biomed) is manufacturer trained and could not duplicate the reported issue with the centrifugal drive motor.The biomed has requested the field service representative (fsr) to check out the centrifugal drive motor.

Manufacturer Narrative

(b)(4).The field service representative (fsr) inspected the centrifugal motor and noted that the window on the motor was cracked and somewhat pushed into the magnets.The fsr installed a different centrifugal motor onto the system 1 base.With the alternate device installed, the unit was tested and operated properly.The unit was released for clinical use.The user facility biomedical engineer (biomed) will send the device to the manufacturer for further evaluation and repair.

Manufacturer Narrative

(b)(4).During laboratory analysis, the product surveillance technician (pst) could not duplicate the reported complaint.Although the lab use only (luo) centrifugal pump remained coupled throughout evaluation, the pst observed a loose connection between the luo centrifugal pump and the device under test (dut) centrifugal motor caused by a worn retainer.The product will be sent to service to be brought to manufacturers specifications before being returned to clinical use.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: SARNS CENTRIFUGAL SYSTEM
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
• 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: 5790244
• MDR Text Key: 50177402
• Report Number: 1828100-2016-00500
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/11/2016

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: 164267
• Device Catalogue Number: 164267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/05/2016; 10/07/2016; 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2004
• 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