MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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Model Number HL 20 |
Device Problem
Failure to Pump (1502)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The user reported that the hl20 pump displayed the error message: "safety-s¿ intermittently.No harm to any person was reported.The technician tested the pump for functionality, resetted all connections and observe the pump for more than two hours, no error was found.The hl 20 machine was working fine.Thus the reported failure could not be confirmed.However this reported error message "safety-s" could be linked to the following root cause: an error occurs when transmitting the signals via the control board to the safety system board.This causes that the safety system board to receive no or incorrect data and therefore triggers the error message: "safety-s".With reference to the hl20 risk assessment (risk id: h1.1.1.2.7) this event can be contributed to: wrong pump speed because of: communication error (e.G.Wrong ratio between master-slave pumps due to communication error).Device was manufactured in 2013-02-26.The review of the non-conformities during the period of 2013-02-26 to 2022-11-15 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences are unlikely.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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Event Description
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The user reported that the hl20 pump displayed the error message: "safety-s¿ intermittently.No harm to any person was reported.The technician tested the pump for functionality, resetted all connections and observe the pump for more than two hours, no error was found.The hl 20 machine was working fine.Complaint id# (b)(4).
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