MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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Model Number ROTAFLOW |
Device Problems
Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2021 |
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.
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Event Description
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It was reported that a rotaflow displayed the error message ¿head error¿.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 displays the error message "head error".A getinge service technician repaired the affected rotaflow in the repair center on 2021-05-06.The technician replaced the 70101.1675 rfc (rotaflow console) power supply board.The device passed all tests and is working as intended.The 70101.7188 battery pack with fuse has been replaced as part of the 2 year preventative maintenance.The most probable root cause could be determined as the rotaflow drive with the serial number (b)(6) has bent pins which blew the fuse f4 on the power supply board.This rotaflow drive will be handled in complaint (b)(4).The product in question was produced in 2019-04-01.The review of the non-conformities has been performed on 2021-05-07 for the period of 2019-04-01 to 2021-05-07.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.Based on these investigation results the reported failure could 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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Search Alerts/Recalls
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