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 05/25/2022 |
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 user facility reported that a 2008k2 hemodialysis (hd) machine experienced a saline bag backfill during the setup (prime) process in dialysis mode.The field service technician (fst) stated there is an air separator adapter board installed on this machine.The fst verified there was no patient involvement associated with the reported issues.The machine was in the setup process in dialysis mode when this occurred.User error was not a contributing factor.The machine had 31,973 hours on it at the time of the event.The machine did not give any filling programs.The fst confirmed the machine had upgrades for the changes being effected (cbe) completed, and verified that the drain line length and height were within specification.To resolve the reported issue, the fst replaced the air separator assembly piggy back board on the distribution board position number six and the tmp was calibrated.The machine was subsequently returned to service.The used parts were not available to be returned for evaluation.
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Manufacturer Narrative
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Initial submission date received 05/25/2022.
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Event Description
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A user facility reported that a 2008k2 hemodialysis (hd) machine experienced a saline bag backfill during the setup (prime) process in dialysis mode.The field service technician (fst) stated there is an air separator adapter board installed on this machine.The fst verified there was no patient involvement associated with the reported issues.The machine was in the setup process in dialysis mode when this occurred.User error was not a contributing factor.The machine had 31,973 hours on it at the time of the event.The machine did not give any filling programs.The fst confirmed the machine had upgrades for the changes being effected (cbe) completed, and verified that the drain line length and height were within specification.To resolve the reported issue, the fst replaced the air separator assembly piggy back board on the distribution board position number six and the tmp was calibrated.The machine was subsequently returned to service.The used parts were not available to be returned for evaluation.
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Investigation determines that there was causal relationship between the objective evidence and the alleged event; the alleged event is confirmed.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 able to be confirmed.
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Event Description
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A user facility reported that a 2008k2 hemodialysis (hd) machine experienced a saline bag backfill during the setup (prime) process in dialysis mode.The field service technician (fst) stated there is an air separator adapter board installed on this machine.The fst verified there was no patient involvement associated with the reported issues.The machine was in the setup process in dialysis mode when this occurred.User error was not a contributing factor.The machine had 31,973 hours on it at the time of the event.The machine did not give any filling programs.The fst confirmed the machine had upgrades for the changes being effected (cbe) completed, and verified that the drain line length and height were within specification.To resolve the reported issue, the fst replaced the air separator assembly piggy back board on the distribution board position number six and the tmp was calibrated.The machine was subsequently returned to service.The used parts were not available to be returned for evaluation.
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Search Alerts/Recalls
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