CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 191126 |
Device Problem
Melted (1385)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/28/2020 |
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 2008t hemodialysis (hd) machine had a burning smell.A fresenius field service technician (fst) went onsite and observed that the bibag interface board melted to the bibag interface cable that connects to distribution box 2.The fst did not observe any smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the burning smell and melted parts.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine had approximately 200 hours at the time the malfunction occurred.There was no damage observed on any other components or any other additional issues associated with the melted bibag interface board and bibag interface cable.The bibag interface board and bibag interface cable were replaced to resolve the reported issue, and the machine was returned to service without issue and without reoccurrence of the event.
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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).To resolve the reported issue, the fst replaced the bibag interface board and the bibag interface cable.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 confirm the reported failure mode.During the machine inspection, the fresenius fst observed that the bibag interface cable melted to the bibag interface board.Therefore, the complaint event was confirmed.
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Manufacturer Narrative
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Plant investigation: the bibag interface board and the hydraulics distribution cable were returned to the manufacturer for a physical evaluation.The complaint samples were returned to the manufacturer connected.A visual inspection of the complaint samples indicated burn damage to the j4 connector of the bibag interface board and the end connector of the hydraulics distribution cable.Further inspection showed signs of concentrate around the complaint samples.The complaint samples were installed into a test machine to test for the reported failure.The test machine was able to power up and perform a rinse without experiencing any problems, including any signs of any signs of smoke, spark, flame, arcing, or burning smell.No additional damage was done to the complaint samples during testing.The concentrate found on the bibag interface board and hydraulics distribution cable is a possible cause of the short that occurred with the electrical circuitry of the bibag interface board and the subsequent burn damage that was the sustained by the complaint samples.
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