Model Number MCP00706291#ROTAFLOW PUMP MODULE |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 the error message ¿head error¿ occurred on the rotaflow console and drive.No more information provided.No harm to any person has been reported.Complaint id: (b)(4).
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Manufacturer Narrative
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The event occurred in china.It was reported that the error message ¿head error¿ occurred on the rotaflow console and drive during the pre-charge process and no patient was involved.No harm to any person has been reported.The affected rotaflow console (rfc) with s/n number 94175797 and the rotaflow drive (rfd) with s/n 910130187 were investigated by a getinge field service technician and the technician was able to confirm the the reported "head error" on the rfd.The involved rfc has no malfunction and no parts has been replaced on the rotaflow console.The affected rfd needs to be repaired by the supplier.Rotaflow drive (rfd) with s/n 910130187 will be send back to the supplier emtec for repair.The following most possible root cause could be determined for the head error: the head error is caused by the hot plug.When the device is in operation and the power plug is plugged in or out the head error occurs and the rota flow drive and / or the control board is damaged.As a result the rota flow drive and / or the control board has to be replaced.Based on these investigation results the reported failure "head error" could be confirmed.A device history record (dhr) review was performed on 2021-12-28.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.In order to avoid reoccurrence of the reported failure, the sales and service unit (ssu) will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.4 | en | v15.Chapter 4.1.3: switch off the rotaflow console on/off switch before connecting the rotaflow drive to or disconnecting it from the rotaflow console.Otherwise the rotaflow console may be damaged.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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