Catalog Number 190766 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Death (1802)
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Event Date 04/02/2018 |
Event Type
Death
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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 user facility nurse manager reported a patient who coded during hemodialysis (hd) treatment.The patient was in an acute facility and was chronically ill and in critical condition.The patient coded during treatment and treatment was discontinued.The nurse manager reported that the patient recovered from the event, however, subsequently passed away later that day on (b)(6) 2018.The nurse manager stated that the patient was not a chronic dialysis patient and that dialysis therapy was used as a last attempt to help the patient.The machine was sequestered after the event.A fresenius regional equipment specialist (res) was called onsite to perform a machine evaluation per hospital policy.The nurse manager stated that there was no allegation of product deficiency or malfunction on or against the machine or any fresenius device(s).The res technician verified operation of the machine and the machine was found to be functioning as per specification and functional tests performed.The machine was placed back in service.Additional information regarding the patient and the event was requested, however, not provided by the facility.
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Manufacturer Narrative
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Additional information: clinical investigation clinical investigation: a temporal relationship exists between the hemodialysis (hd) therapy utilizing the 2008t hd machine and the adverse event of death.Based on the information available, the etiology of the hospitalization and eventual expiration of the patient is unknown.It is known however, that end stage renal disease (esrd) patients receiving renal replacement therapy (rrt) have a higher mortality rate.Therefore, based on the information available, causality cannot be determined.There is no evidence or documentation in the file which establishes a causal relationship between the event of death and the 2008t hd machine.Additionally, there is no report of a malfunction or of the machine failing to perform as expected.This is further emphasized by the clinical manager's statement in which it was stated there were no allegations being levied against the machine.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res) due to the reported event.The res evaluated the machine.The machine underwent functional checks and all tests found the unit to be functioning within specification and no repairs were made.A records review was performed on the reported device serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformance's, or any associated rework during the manufacturing process which could be related to the reported event.Additionally, a review of the device history record (dhr) confirmed the results of the in-progress and final quality control (qc) testing met all the requirements.The investigation into the cause of the reported problem was not able to be confirmed.
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Search Alerts/Recalls
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