CONCORD MANUFACTURING 2008K OLC ONLY WITH HEPARIN PUMP; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 2008K |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.
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Event Description
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A user facility medwatch report was received which detailed a blood loss event that occurred while a patient underwent a hemodialysis (hd) treatment.At the start of the patient's hd therapy, the 2008k hemodialysis (hd) machine generated a blood leak alarm.Although no blood leak was visible, the blood pump was not able to be restarted, as the blood leak alarm recurred each time the treatment was re-initiated.The caregiver was unable to return the blood within the extracorporeal circuit.The patient was switched to another hd machine, and then the treatment was continued and successfully completed.No patient adverse effects were experienced and no medical intervention was required as a result of this event.
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Manufacturer Narrative
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The device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.No system repair activities have been identified.Therefore, the current state of the machine is not known.Follow-up has been requested from the risk manager, but has not been made available.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 deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the material and process controls were within specification.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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