MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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Model Number ROTAFLOW |
Device Problem
Gradient Increase (1270)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2021 |
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 was requested from the sales and service unit, but has not been received yet.
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Event Description
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It was reported that after a few minutes the flow measurement of the liter per minute (lpm) increases.The revolutions stay the same.When the maximum allowed level is reached the device emits an acoustic alarm.The failure occurred during patient treatment.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 was that the rotaflow "flow measurement increases".A getinge service technician replaced the 70101.1681 rfc (rotaflow console) flow measure board to solve the reported failure.The rotaflow has been working as intended again.The affected 70101.1681 rfc flow measure board was sent back to the manufacturer for further investigations.It was received on 2021-04-12 and during the investigation by the life-cycle-engineering (lce) on 2021-04-27 the reported "flow measurement increases" could not be confirmed.However the failure mode "flow measurement increases" can be linked to the following most possible root causes according to our risk management file (dms# 2023689).Malfunction of the flow measurement system: incorrect flow measurement.Device used out of specification.Bubble/flow sensor failure, e.G.: malfunction of bubble/flow sensor electronics.Device used out of specification.A device history review (dhr) was performed on 2021-03-02 and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.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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