MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2018

Event Type  Injury  

Manufacturer Narrative

The motor is not a single use device.Approximate age of the device will be provided with the results of the device analysis.The device is expected to be returned for evaluation.It has not yet been received no further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that during testing of the system, a motor disconnected alert occurred whenever the pump motor was moved up or down.There was no patient involvement with this event.The motor will be returned to the manufacturer for evaluation.No additional information was reported.

Event Description

It was reported that during testing of the system, a motor disconnected alert occurred whenever the pump motor was moved up or down.There was a concern for about a motor cable issue.The motor will be returned to the manufacturer for evaluation.There was no patient involvement with this event.No additional information was reported.

Manufacturer Narrative

It was noted that information was inadvertently omitted from the initial submission."there was a concern for about a motor cable issue." has been added to the event problem.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event was confirmed through the evaluation of the returned centrimag motor.The returned centrimag motor was evaluated by abbott technical services personnel.While running the system, the reported complaint was able to be duplicated with manipulation of the motor cable.The pump started crashing and a motor connection error was displayed.These failures were consistent with the preliminary findings of the product performance engineering team during electrical continuity testing of the motor cable upon receipt of the unit, which found an intermittent open connection in the cable line when bending the cable near the motor housing.The evaluation deemed the unit defective and the centrimag motor was scrapped.A capa has been initiated to further investigate the issue of breakdown in centrimag motor cables.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8198211
• MDR Text Key: 131490485
• Report Number: 2916596-2018-05591
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0103-2019
• Patient Sequence Number: 1