MAUDE Adverse Event Report: PERFUSION SYSTEMS BIOMEDICUS EXTERNAL DRIVE UNIT; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 540T

Device Problems Excess Flow or Over-Infusion (1311); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/15/2014

Event Type  malfunction  

Event Description

Medtronic received information that during bypass a bio-console used in conjunction with this external motor drive displayed a motor controller malfunction error and the rpm (revolutions per minute) increased to the maximum limit.The flow was controlled by using the clamp on the arterial-line.The user turned off the pump speed knob to reset the rpms and the pump returned to normal status.The unit was then used to complete the case with no adverse effects on the patient.The external motor drive is expected to be returned to medtronic for analysis.

Manufacturer Narrative

Upon receipt at medtronic¿s service depot, analysis of the external motor drive determined that the motor speed increased to maximum speed due to an intermittent motor cable connection in the external motor drive.The product was scrapped.

• Brand Name: BIOMEDICUS EXTERNAL DRIVE UNIT
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3911252
• MDR Text Key: 17259243
• Report Number: 2184009-2014-00047
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K070286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2014

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: 540T
• Device Catalogue Number: 540T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/1998
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00069 YR
• Patient Weight: 59