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
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/28/2021 |
Event Type
Injury
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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.Clinical investigation: a probable temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system and the unspecified serious adverse event(s), characterized by the sequestering of the device.The etiology of the unspecified event(s) is unknown; therefore, causality cannot be established.Limited information precluded a thorough investigation into the unspecified event(s).While advances in technology have significantly reduced the number of serious adverse events incurred during hd therapy, the 2008t hemodialysis system cannot be excluded from having a possible causal or contributory role in the unspecified serious adverse event(s).There is no direct allegation or objective evidence indicating the 2008t hemodialysis system malfunction or deficiency caused the serious adverse event(s).However, given the lack of event(s) specifics (e.G., hd treatment data, patient demographics, discharge summary, death certificate, esrd death notification), the 2008t hemodialysis system cannot be disassociated from the events.
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Event Description
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A user facility biomedical technician (biomed) contacted fresenius to request onsite testing be performed on a 2008t hemodialysis (hd) machine.Reportedly, the machine had been sequestered following an unspecified event.A fresenius field service technician (fst) was dispatched to the facility to perform functional compliance testing on the system.The machine passed all testing and performed as expected per the manufacturer specifications.Upon follow-up, the biomed stated they were instructed not to discuss the case with anyone, and thus, no event details were provided.Additionally, the fst who performed the testing reported that they were not informed of what had occurred.Subsequent attempts to obtain additional information have thus far proven unsuccessful.
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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 fst reported that the machine passed all functional checks.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 fresenius fst was unable to identify any problems with the hemodialysis (hd) machine during testing.The 2008t hd machine performed as designed and no problems were detected.
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Event Description
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A user facility biomedical technician (biomed) contacted fresenius to request onsite testing be performed on a 2008t hemodialysis (hd) machine.Reportedly, the machine had been sequestered following an unspecified event.A fresenius field service technician (fst) was dispatched to the facility to perform functional compliance testing on the system.The machine passed all testing and performed as expected per the manufacturer specifications.Upon follow-up, the biomed stated they were instructed not to discuss the case with anyone, and thus, no event details were provided.Additionally, the fst who performed the testing reported that they were not informed of what had occurred.Subsequent attempts to obtain additional information have thus far proven unsuccessful.
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