Model Number 701044054 - HCU 40 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental medwatch will be submitted after new information has been received.
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Event Description
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It was reported that the hcu 40 had a pump stop during cleaning cycle.Complaint number: (b)(4).
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Event Description
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Complaint number: (b)(4).
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Manufacturer Narrative
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According to the service report#(b)(4) dated on (b)(6)2019 the field service technician (fst) replaced the hcu 40_valve kit (flow & 3-way) (material#70107.1778, serial#unknown).The fst performed the diagnosis and passed all the specifications.The device is back in clincal use.No root cause determination is applicable, the defective part is not available for investigation.The reported failure could be confirmed.The ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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Search Alerts/Recalls
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