THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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Model Number 201-90411 |
Device Problems
Decreased Pump Speed (1500); Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
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Event Description
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The patient was implanted with a left ventricular assist device (lvad).It was reported on (b)(6) 2018 that the following event regarding centrimag vv ecmo patient with hvad pump as lvad support and using centrimag for vv ecmo support had rattling noise and had an s3 system alert alarm observed.At the same time, the speed dropped from set speed of 4300rpm to 3500rpm.Clinicians tried to increase speed back up to 4300rpm but speed would not increase.The patient still had forward flow throughout the event.Ecmo specialists and nursing staff tried to re-seat the patient's pump motor to fix the rattling sound and clear the s3 alarm, which did not work and the reported motor noted to be very hot.The perfusionist, nursing, intensivist were all present for troubleshooting and inspected the circuit for clots in circuit but they did not see anything.Throughout the troubleshooting, the patient still had forward flow, however the pump was unable to maintain the speed of 4300rpm and s3 alarm was going off without ability to clear, while pump still made the rattling sound inside motor during the troubleshooting time frame.The team replaced the cmag motor and primary console and the flow probe to backup the system, during which time they increased vent to 100%.No issues occurred following system replacement and no further alarms were reported after exchange.No adverse effects for patient were noted by clinicians due to the reported event or due to any system replacement.No further information was provided.
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Manufacturer Narrative
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Manufacturing evaluation conclusion: the report of an s3 alarm and speed drop from 4300rpm to 3500rpm was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console.The log file contained approximately 21 hours of data (dated (b)(6) 2018 - (b)(6) 2018, according to the timestamp).The system was operational for approximately 86 hours and was supporting the pump at approximately 4300rpm and a flow of approximately 4.1lpm.At approximately 4:12am on (b)(6), 2018 the console alarmed with an active system alert: s3.During this event speed dropped to approximately 3400rpm and the flow reading dropped to 0lpm, consistent with reported information.Multiple attempts to adjust the set speed above 3400rpm were unsuccessful.However, when speed was set to 2900rpm, the console responded as designed.The flow reading remained at 0lpm until the console was powered down.The returned centrimag 2nd gen primary console was evaluated and tested by tech service under work order # (b)(4).The reported events were not reproduced during their testing.The console was tested along with its related motor.No alarms or atypical events were reproduced during testing.The pump's flow always remained at the set levels with no issues.During testing it was noted that the console's battery was due for its routine maintenance.Battery maintenance was performed without any issues.The console was functionally tested per the centrimag 2nd gen primary console service process and the unit passed all tests.The returned console was found to function as intended.As a result, the root cause of the events captured in the data log file could not be conclusively determined.The tested unit was returned to the customer site.Reports of similar events will continue to be tracked and monitored.
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Manufacturer Narrative
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Section d10, f9, h4, h10: correction.Section f9: approximate age of device - 7 months.No further information was provided.The manufacturer is closing the file on this event.
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