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 06/16/2022 |
Event Type
malfunction
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Event Description
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A fresenius field service technician (fst) was called onsite after a biomed at a user facility reported that a fresenius 2008k2 hemodialysis (hd) machine had a saline bag backfill during set-up for use.The fst stated during followup that backfill was visually observed by the facility staff during prime.A patient was not connected to the machine at the time of the incident.The biomed reported that there were no quick disconnects on the drain line and that the drain line length and height were within specification.The biomed confirmed that the unit has received the cbe hardware and software upgrades.The fst replaced the air separator assembly to resolve the reported issue.The machine is back in service without reoccurrence of the reported event.No parts were returned to the manufacturer for a physical evaluation.
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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 fresenius field service technician (fst) was called onsite after a biomed at a user facility reported that a fresenius 2008k2 hemodialysis (hd) machine had a saline bag backfill during set-up for use.The fst stated during followup that backfill was visually observed by the facility staff during prime.A patient was not connected to the machine at the time of the incident.The biomed reported that there were no quick disconnects on the drain line and that the drain line length and height were within specification.The biomed confirmed that the unit has received the cbe hardware and software upgrades.The fst replaced the air separator assembly to resolve the reported issue.The machine is back in service without reoccurrence of the reported event.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.However, an on-site evaluation was performed by a fresenius field service technician (fst).The fst replaced the air separator assembly to resolve the reported issue.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 manufacturer was able to determine during their investigation a causal relationship between the objective evidence and the alleged event; the alleged event is confirmed.
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Search Alerts/Recalls
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