MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 102954

Device Problem Misconnection (1399)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the centrimag motor had issues with centering the rotor.The motor would not connect properly to the centrimag console.Additional information was received that the cause of the issue was not identified and the issue did not resolve.The motor was removed from use and returned for analysis.There were no patient consequences.Related mfr.Report number: 3003306248-2022-00041.

Manufacturer Narrative

G2: health professional was selected inadvertently.Manufacturer's investigation conclusion: the reported event of the motor not connecting properly to the console was not confirmed.The centrimag 1st generation primary console was not returned for analysis.Additional provided information communicated on 03mar2022 stated that the serial number of the console is unknown.The cause for the event was not determined and the issue was not resolved.There was no patient consequence.The motor was returned for evaluation.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were unable to be reviewed due to the serial number of the 1st generation primary console being unknown.Centrimag motor instructions for use instructs to always have a back-up centrimag motor available.Centrimag blood pump instructions for use states "always have a spare centrimag blood pump, back-up console and equipment available for change out.".Centrimag primary console operating manual warns "one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag blood pump is used.The back-up console must be connected to the back-up motor, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the primary console or primary motor experience a malfunction.".No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13759828
• MDR Text Key: 289357081
• Report Number: 3003306248-2022-00042
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: 07640135140672
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

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: 102954
• Device Catalogue Number: 102954
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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