Model Number 106531 |
Device Problems
Electrical /Electronic Property Problem (1198); Communication or Transmission Problem (2896); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2022 |
Event Type
malfunction
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Event Description
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It was reported that an unknown controller fault occurred on (b)(6) 2022.
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Manufacturer Narrative
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No additional information has been provided.The manufacturer is closing the file on this event.
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Event Description
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It was reported that the cause of the controller faults was due to an outflow graft obstruction.The alarms have resolved.Related manufacturer report number: 2916596-2022-12233.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the system controller (serial #: (b)(6)) is being evaluated for the reported event of controller fault alarms.The system controller was not returned for analysis; however, 2 log files were submitted for review with overlapping events spanning approximately 9 days (04jul2022 ¿ 13jul2022 per time stamp).Low flow alarms were active between 06jul2022 at 20:22:40 to 07jul2022 at 16:43:36 due to the flow falling below the low flow threshold.Intermittent replace controller alarms/yellow wrench advisories/backup mcu faults (internal error code 50) beginning on 13jul2022 at 18:31:46 ¿ 19:08:19.During this time period, there was also elevated pump power and some low speed events.There were no other notable alarms active in the log file.Additional provided information stated that the cause of the controller faults, low speed, and power elevations were due to an outflow graft obstruction.The alarms/events have resolved.The device history records were reviewed for the system controller (serial #: (b)(6)) and the system controller was found to pass all manufacturing and quality assurance specifications.Heartmate ii instructions for use (ifu) section 7 entitled ¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly address and interpret all system alarms including low speed, low flow, and yellow wrench advisory alarms.Heartmate ii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate ii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly maintain and store the equipment for proper use.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
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Event Description
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It was reported that patient was experiencing frequent low flow alarms, prompting a computed tomography (ct) scan to be collected for evaluation.The scan revealed a possible thrombus formation between the outflow graft bend relief / lumen.The patient was taken to the operating room (or) on (b)(6) 2022 to replace the outflow graft; however, during surgery manipulation of the bend relief released beige purulent drainage.The gore-tex / outer covering of the outflow graft was removed, and the outflow graft replacement was otherwise aborted, with cultures being taken of the drainage.The procedure improved the ventricular assist device (vad) flow after the extrinsic compression was removed, per the account.The blood cultures never came back positive for an infection, and the beige fluid was believed to be due to the oxidation of the gore-tex layering.The patient remained ongoing on (b)(6).Additional log files revealed intermittent controller faults, replace controller alarms, along with elevated powers and speed drops, had occurred on 13jul2022.The account stated that the cause of the alarms, low speeds, and power elevations were due to the outflow graft obstruction.Related manufacturer report number: 2916596-2022-12233.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the system controller (serial #: (b)(6) is being evaluated for the reported event of controller fault alarms.The system controller was not returned for analysis; however, 2 log files were submitted for review with overlapping events spanning approximately 9 days (b)(6) 2022per time stamp).Low flow alarms were active between (b)(6) 2022 at 16:43:36 due to the flow falling below the low flow threshold.Intermittent replace controller alarms/yellow wrench advisories/backup mcu faults beginning on (b)(6) 2022 at 18:31:46 ¿ 19:08:19.During this time period, there was also elevated pump power and some low-speed events.There were no other notable alarms active in the log file.This event is further investigated via the pump investigation (related manufacturer report number: 2916596-2022-12233.).The device history records were reviewed for the system controller (serial #: (b)(4) and the system controller was found to pass all manufacturing and quality assurance specifications.Heartmate ii instructions for use (ifu) section 7 entitled ¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly address and interpret all system alarms including low speed, low flow, and yellow wrench advisory alarms.Heartmate ii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate ii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly maintain and store the equipment for proper use.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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