Catalog Number 190305 |
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 03/14/2022 |
Event Type
malfunction
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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 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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Event Description
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A biomedical technician (biomed) at a user facility reported that a fresenius 2008k hemodialysis (hd) machine had a saline bag backfill in recirculation mode, during set-up for use.There was no patient involvement associated with the event.The biomed did not report that there were any machine alarms.Multiple attempts were made to contact the biomed and obtain additional information.Thus far, those attempts have proven unsuccessful.It is unknown if any parts were replaced and/or if they are available to be returned for physical evaluation.
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Manufacturer Narrative
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Correction: e3 was inadvertently omitted from initial report.
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Event Description
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A biomedical technician (biomed) at a user facility reported that a fresenius 2008k hemodialysis (hd) machine had a saline bag backfill in recirculation mode, during set-up for use.There was no patient involvement associated with the event.The biomed did not report that there were any machine alarms.Multiple attempts were made to contact the biomed and obtain additional information.Thus far, those attempts have proven unsuccessful.It is unknown if any parts were replaced and/or if they are available to be returned for physical evaluation.
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Search Alerts/Recalls
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