CONCORD MANUFACTURING 2008T HD SYS. W/O CDX BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 191128 |
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 03/02/2022 |
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 hemodialysis (hd) user facility reported that a fresenius 2008t hd machine experienced a saline bag filling error and had high transmembrane pressure (tmp).A fresenius field service technician (fst) was dispatched to the facility to evaluate the machine.Additional details were revealed when the fst arrived onsite.The clinic manager (cm) at the facility explained to the fst that the machine was set up incorrectly and the saline backfill was caused by use error.The cm told the fst that one of the lines was left unclamped.Per the cm, they changed the setup and it resolved the issue.However, the tmp was still high.It was confirmed that this occurred during priming; there was no patient involvement.During testing, the fst could not duplicate the saline bag filling error or the high transmembrane pressure (tmp) problem.As a precaution, the fst calibrated the dialysate pressure.They also calibrated the bicarb pump and the concentrate pump.The fst confirmed that the cbe upgrades had been completed on the machine, and that there were no reports of the machine giving any filling programs.The fst said the machine was returned to service upon their departure, and they did not have any knowledge of there being further issues.The saline bag filling error was caused by use error, and this was acknowledged by the reporting facility.
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Event Description
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A hemodialysis (hd) user facility reported that a fresenius 2008t hd machine experienced a saline bag filling error and had high transmembrane pressure (tmp).A fresenius field service technician (fst) was dispatched to the facility to evaluate the machine.Additional details were revealed when the fst arrived onsite.The clinic manager (cm) at the facility explained to the fst that the machine was set up incorrectly and the saline backfill was caused by use error.The cm told the fst that one of the lines was left unclamped.Per the cm, they changed the setup and it resolved the issue.However, the tmp was still high.It was confirmed that this occurred during priming; there was no patient involvement.During testing, the fst could not duplicate the saline bag filling error or the high transmembrane pressure (tmp) problem.As a precaution, the fst calibrated the dialysate pressure.They also calibrated the bicarb pump and the concentrate pump.The fst confirmed that the cbe upgrades had been completed on the machine, and that there were no reports of the machine giving any filling programs.The fst said the machine was returned to service upon their departure, and they did not have any knowledge of there being further issues.The saline bag filling error was caused by use error, and this was acknowledged by the reporting facility.
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Manufacturer Narrative
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Additional information: h3 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 saline bag filling error was determined to be caused by use error.As a precaution, the fst calibrated the dialysate pressure, the bicarb pump, and the concentrate pump.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 fst could not duplicate the saline bag filling error or the high transmembrane pressure (tmp) problem.It was confirmed that the reported failure was caused by use error.Based on the available information, the reported failure mode could not be confirmed.
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