MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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Model Number ROTAFLOW |
Device Problems
Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A follow-up medwatch will be submitted when additional information becomes available.Further information has been requested but not yet received yet.
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Event Description
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It was reported that flow rate of the rotaflow suddenly increased to about 7l/minute while they were using the reservoir at a level that the level sensor could just barely detect.The customer tried to adjust the flow, but the rotary knob did not react.The device was turned off to stop the rotaflow.The surgery was continued with the rotaflow emergency drive until the device has been exchanged with a backup device.Complaint id:(b)(4).
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Event Description
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Complaint id: (b)(4).
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Manufacturer Narrative
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The initial failure description "flow increased and rotary knob function is impaired" occurred during patient treatment.The device has been exchanged with a backup device.No patient harm occurred.A getinge service technician investigated the affected rotaflow with the serial number (b)(6).The technician could not reproduce the reported failure.The device is working as intended.The product in question was produced 2017-09-16.The review of the non-conformities has been performed on 2021-04-20 for the period of (b)(6) 2017 to (b)(6) 2021.It 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 can be excluded.However the failure mode "flow increased and rotary knob function is impaired" can be linked to the following most possible root causes according to our risk management file (dms# (b)(4)).Malfunction of the microcomputer system: 1.Volatile memory failure 2.Failure on other device parts (rotary knob, display, etc).Bubble/flow sensor failure: 1.Malfunction of bubble/flow sensor electronics 2.Dried contact gel 3.User forgot renewing contact gel 4.Device used out of specification.Based on these investigation results the reported failure could not be confirmed.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.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.
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