MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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Model Number MCP00967621#RFD 20-973 ROTAFLOW DRIVE |
Device Problem
Noise, Audible (3273)
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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 12/26/2020 |
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.
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Event Description
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It was reported from a customer in (b)(6) that a va ecmo has been running since december 17th.Notified by the intensive care staff on december 26th that the rotaflow drive (sn (b)(4)) is suddenly very loud.The sound is described as a "grinder".The rotaflow drive runs without any problems.Customer changed the rotaflow drive.The exchange was without consequences for the patient.No harm to the patient was reported.Complaint id: (b)(4).
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Manufacturer Narrative
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The event occurred in germany.It was reported that a va ecmo has been running since (b)(6).Notified by the intensive care staff on december 26th that the rotaflow drive (sn (b)(6) ) is suddenly very loud.The sound is described as a "grinder".The rotaflow drive runs without any problems.Customer changed the rotaflow drive.The exchange was without consequences for the patient.The affected rotaflow drive (rfd) with s/n (b)(6) was sent back to manufacturer for repair.It was received on 2021-02-10 and during investigation by the service department on 2021-02-15 the reported failure "grinding noise on the rfd " could be reproduced.The drive was sent to the supplier emtec on 2021-02-24 for further investigation.On 2021-04-09 emtec could reproduce the reported failure "noise".The root cause was determined as worn bearings due to wear of the device (the rfd was built before 2004).The parts will be replaced by the supplier.Furthermore, it was detected that the flow sensor showed discoloration due to aging.The sensor worked as indented.The supplier recommended to exchange the aged flow sensor as preventative maintenance.The sales and service unit has been informed by the service department about the recommendation.The review of the non-conformities has been performed on 2020-12-30 for the period since 2004 to 2020-12-30.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.The product in question was produced before 2004.Based on these investigation results the reported failure could be confirmed.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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Complaint id: (b)(4).
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Search Alerts/Recalls
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