Model Number 2008T |
Device Problem
Pumping Problem (3016)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The plant investigation is in progress.A supplemental medwatch will be submitted at the completion of this activity.
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Event Description
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The user facility clinic manager reported intermittent trans membrane pressure (tmp) fluctuations on a 2008t hemodialysis (hd) machine while a patient underwent their hd treatment.Reportedly, this event led to blood beginning to clot within the extracorporeal circuit which subsequently resulted in blood loss.The patient's estimated blood loss (ebl) was noted as being approximately 300 milliliters (ml).Following this event, the 2008t hd machine was removed from service for evaluation.Functional testing performed by the biomed confirmed the system was operating properly; no malfunctions were identified.The unit has been returned to service at the user facility without a recurrence of the event as reported.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.The biomedical technician indicated that the unit was pulled from service for evaluation following the event.Functional testing performed by the biomed confirmed that the system was operating properly.The 2008t hemodialysis (hd) machine was returned to service at the user facility 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 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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Search Alerts/Recalls
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