MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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Model Number MCP00703157#RFC 20-970 ROTAFLOW CONSOLE |
Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/13/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.
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Event Description
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The event occurred in (b)(6).It was reported that flow rate display of rotaflow console (rfc) no longer shows the correct value.It was noticed until 2-3 hours after the rotaflow patient circuit was replaced and the hospital staff noticed that the flow rate values were not correct.Customer was able to notice it because they connected an external flow meter to the rotaflow circuit.Re-setting the rf-32 and reapplying contact cream did not seem to improve the problem.There was no problem with the operation, but just to be sure, they replaced the rfc with another device that was in the hospital.The hospital staff verified it after use, but the problem was not reproducible.No indication of actual or potential for harm or death has been reported.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 event occurred in japan.It was reported that flow rate display of rotaflow console (rfc) no longer shows the correct value.The rotaflow patient circuit was replaced and after 2-3 hours the hospital staff noticed that the flow rate values were not correct.Customer was able to notice it because they connected an external flow meter to the rotaflow circuit.Re-setting the rf-32 and reapplying contact cream did not seem to improve the problem.It was further reported that no problem was detected during the treatment however the customer replaced the rfc with another rfc preventatively.The hospital staff verified it after use, but the problem was not reproducible.No harm to any person has been reported.The affected rotaflow console with s/n (b)(6) was investigated by a getinge field service technician and the technician could not reproduce the reported failure "flow rate inaccurate".During the investigation the batterypack ni-cd 24v 120wh (rfc) (article number 701017188) has been replaced as part of the performed inspection on the device.Based on the investigation results the reported failure "flow rate inaccurate" could not be confirmed.However the failure mode "flow rate inaccurate" can be linked to the following most possible root causes according to our risk management file (dms# 2023689) dried contact gel user forgot renewing contact gel sensor not detected although sensor is connected device used out of specification.The review of the non-conformities was performed on 2021-12-16 and during the period of 2011-07-22 to 2021-12-16 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 rotaflow console was manufactured in 2011-07-22.In order to avoid reoccurrence of the reported failure "flow rate inaccurate", the sales and service unit (ssu) will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.2 | en | v14.6.2 reapplying ultrasonic contact cream the ultrasonic contact cream can dry out and impair the functioning of the integrated flow/bubble sensor.In the "free" mode, the ultrasonic contact cream must be reapplied every 48 hours or as soon as the error message [sig!] appears.In the "stand al" mode, the ultrasonic contact cream must be reapplied every 48 hours or as soon as the error message [faultbub] appears.The error message [sig!] indicates an error in the integrated flow/bubble sensor, which may result in an incorrect flow display.The rotaflow centrifugal pump still continues to function.If the error occurs during lpm mode, the rotaflow system switches back to rpm mode automatically.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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