MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG CONSOLE MONITOR CABLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-52147

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of one of the monitor¿s connections not working was confirmed and is further investigated under manufacturer report number 2916596-2020-06196.The centrimag console to monitor cable (lot number: l04738) was returned for analysis to mechanical circulatory support (mcs) zurich and was investigated under rma 19-108 by investigator martina wolff.The cable was found to not be correctly assembled.The lemo connector¿s cable collet was not in the right position and the ¿male insert of the connector was position 6mm inwardly.This caused the connector pins, including the 12v power supply pin, to turn to wrong positions.The cable was wrongly connected to the mag monitor causing damage to the mag monitor pcb can-transceiver.The 12v from the console came in contact with the can-input lines and the accidentally flow current damaged the can chip.A manufacturing analysis task was created to further investigate the misassembly of the cable.This analysis found several root causes which will be implemented with the supplier.Abbott will continue to monitor.The root cause for the reported event was conclusively determined to be due to the console to monitor cable not being assembled correctly at manufacturing.The 2nd generation centrimag system operating manual (rev.09) section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, 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 main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual (rev.09) section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual (rev.07) has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.The 2nd generation centrimag system operating manual (rev.09) section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.The incoming inspection was reviewed for the 100 monitor cables of lot number: l04628 and passed before being shipped to the main warehouse on (b)(6) 2016.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer report number: 2916596-2020-06196.It was reported that one of the monitor's connections didn't work.The information provided by the console was not displayed on the monitor.The account tried new cables but the problem remained unsolved.No further information was provided.

• Brand Name: CENTRIMAG CONSOLE MONITOR CABLE
• 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: 11903157
• MDR Text Key: 258699144
• Report Number: 3003306248-2021-02969
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-52147
• Device Catalogue Number: 201-52147
• Device Lot Number: L04728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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