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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 102954
Device Problem Low Readings (2460)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/13/2018
Event Type  malfunction  
Manufacturer Narrative
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
The patient was supported by an extracorporeal circulatory support device.It was reported that low flow alarms had occurred.The motor and console were exchanged and the alarms were resolved.The hospital clinician confirmed it was a low flow alarm on the console.There was no delay in the procedure or adverse event.The patient was reportedly doing fine.No further information was provided.
 
Manufacturer Narrative
The report of low flow alarms was confirmed during the evaluation of a data log file retrieved from the returned centrimag 2nd gen primary console.The log file contained approximately 18 hours and 21 minutes of data (dated 01:09 ¿ 18:21 on (b)(6) 2018).The log file captured frequent ¿flow below minimum: f3¿ alarms.Throughout the log file pump speed was changed multiple times and each time the console responded as designed, supporting the motor at the set speed.However, the transient flow below minimum alarms continued to occur.Despite the flow values being fairly constant, during some of these flow alarms, sporadic drops in flow values were captured (down to as low as 0.5lpm).The returned centrimag 2nd gen primary console was evaluated and tested by tech.The reported complaint could not be verified and was not duplicated during testing.The returned console was operated for an extended period of time with its associated motor as well as with a test motor.The pump's flow always remained at the set levels with no issues.A data log file was retrieved successfully.Full functional checkout was performed per the centrimag 2nd gen primary console service process and the unit passed all tests.As a result, the root cause of the events captured in the retrieved data log file could not be conclusively determined nor correlated to a primary console or motor related issue.The units will be returned to the customer site.Although the root cause of the reported events could not be conclusively determined, based on previous complaint experience, similar events can be a result of a flow probe related issue or a connection issue between the flow probe and the console.However, the flow probe used at the time of the reported events was not returned for analysis.Reports of similar events will continue to be tracked and monitored.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.
 
Manufacturer Narrative
The report of low flow alarms was confirmed during the evaluation of a data log file retrieved from the returned centrimag 2nd gen primary console.The log file contained approximately 18 hours and 21 minutes of data (dated 01:09 ¿ 18:21 on (b)(6) 2018).The log file captured frequent ¿flow below minimum: f3¿ alarms.Throughout the log file pump speed was changed multiple times and each time the console responded as designed, supporting the motor at the set speed.However, the transient flow below minimum alarms continued to occur.Despite the flow values being fairly constant, during some of these flow alarms, sporadic drops in flow values were captured (down to as low as 0.5lpm).The returned centrimag 2nd gen primary console was evaluated and tested by tech.The reported complaint could not be verified and was not duplicated during testing.The returned console was operated for an extended period of time with its associated motor as well as with a test motor.The pump's flow always remained at the set levels with no issues.A data log file was retrieved successfully.Full functional checkout was performed per the centrimag 2nd gen primary console service process and the unit passed all tests.As a result, the root cause of the events captured in the retrieved data log file could not be conclusively determined nor correlated to a primary console or motor related issue.The units will be returned to the customer site.Although the root cause of the reported events could not be conclusively determined, based on previous complaint experience, similar events can be a result of a flow probe related issue or a connection issue between the flow probe and the console.However, the flow probe used at the time of the reported events was not returned for analysis.Reports of similar events will continue to be tracked and monitored.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.
 
Manufacturer Narrative
No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CA CH-80 05
SZ  CH-8005
MDR Report Key7837142
MDR Text Key119047178
Report Number2916596-2018-03567
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
PMA/PMN Number
K093832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 02/27/2020
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 Expiration Date04/30/2020
Device Model Number102954
Device Catalogue Number102954
Device Lot Number6398773
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/14/2018
Initial Date FDA Received08/31/2018
Supplement Dates Manufacturer Received10/30/2018
02/26/2020
Supplement Dates FDA Received11/14/2018
02/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CENTRIMAG MOTOR, L05080-0007
Patient Age55 YR
Patient Weight83
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