Model Number 190610 |
Device Problems
Mechanical Problem (1384); Reflux within Device (1522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/28/2022 |
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 biomedical technician (biomed) at a user facility reported that a fresenius 2008k2 hemodialysis (hd) machine had a saline bag backfill during set-up for use.A patient was not connected to the machine at the time of the incident.Additional information was requested however a response was not received.No parts were returned to the manufacturer for a physical evaluation.
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Event Description
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A biomedical technician (biomed) at a user facility reported that a fresenius 2008k2 hemodialysis (hd) machine had a saline bag backfill during set-up for use.A patient was not connected to the machine at the time of the incident.Additional information was requested however a response was not received.No parts were returned to the manufacturer for a physical evaluation.
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 determined that there was no causal relationship between the objective evidence and the alleged event; therefore the alleged event is unconfirmed.
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Search Alerts/Recalls
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