CONCORD MANUFACTURING 2008K OLC ONLY WITH HEPARIN PUMP; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 190305 |
Device Problems
Thermal Decomposition of Device (1071); Melted (1385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/04/2019 |
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 2008k hemodialysis (hd) machine had a burned and melted bicarb pump wire.It was confirmed the issue was found while the biomed was servicing the machine for a flow error.It was confirmed there was no patient connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.It was confirmed the bicarb pump wire was the original fresenius part on the machine.The clinic has requested a fresenius regional equipment specialist (res) to repair the machine, which remains out of service.The burned component is not available to be returned to the manufacturer for physical evaluation.Additional machine information was requested.If additional information is requested, a supplemental report will be submitted.
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Manufacturer Narrative
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Plant investigation: although it was stated that the complaint device was available to be returned, to date no parts were returned to the manufacturer for physical evaluation.Additionally, an on-site evaluation has not yet been performed by a fresenius regional equipment specialist (res).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 burned and melted bicarb pump wire.It was confirmed the issue was found while the biomed was servicing the machine for a flow error.It was confirmed the machine had not had past problems failing the electrical leakage test, and confirmed the machine was plugged into a gfci outlet.It was confirmed there was no patient connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.It was confirmed the bicarb pump wire was the original fresenius part on the machine.A fresenius regional equipment specialist (res) serviced the machine, and reportedly replaced the distribution board, the retaining plate for the heater block, the concentrate pump stepper, and the hydrochamber to resolve the machine issues and to return it to service.The res service confirmation states ¿the customer stated there had been a small fire at the distribution board bicarbonate pump connector¿.Upon follow up with the biomedical technician at the clinic, it was confirmed there was no fire or flame seen by either the biomed or any other staff at the clinic.The biomed confirmed there was visible heat damage to the distribution board bicarbonate pump connector.It was confirmed that the machine has 29,725 hours of use on it.After repair, the machine passed all functional checks and returned to service.The burned component is not available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.An on-site evaluation was performed by a fresenius regional equipment specialist (res).The res advised they were initially called in to troubleshoot a low flow error.The res found the machine in a state of disassembly.The res installed a new distribution board (provided by the customer) and began reassembling the machine.After reconnecting wiring, tubing, valves, the machine ran in rinse and heat disinfect, but there was an issue in dialysis mode.The res continued to troubleshoot, but was hampered by having to repair leaks.The res explained the machine is from 2003, and when the clinic biomedical technician replaced the hydraulic components, the hoses and tubing had lost elasticity and did not maintain good seals.The res found the wires of balancing chamber valves 35 and 37 reversed, and stated that after he correctly reconnected the wires, the balancing chamber cycled normally, but temperature would not come up.Due to heat damage to the heater and the hydroblock, the res replaced the hydroblock assembly.The res then resolved a low conductivity issue by replacing the concentrate pumps with ones from the clinic's stock.The res continued testing the machine and found no more errors.All self-tests and function tests were performed without 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.
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