Model Number 2008K2 HEMODIALYSIS SYS |
Device Problem
Melted (1385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
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Event Description
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A user facility reported a fresenius 2008k2 machine with an unspecified melted component.It was confirmed that a patient was not connected to the machine, and there was no patient involvement.Due diligence attempts were exhausted, but additional information was not provided.If additional information is received, a supplemental report will be submitted.
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Due diligence attempts were exhausted, but additional information was not provided.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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Search Alerts/Recalls
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