Catalog Number UNKNOWN- 2008T MACHINE |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Vomiting (2144); Loss of consciousness (2418)
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Event Date 03/04/2022 |
Event Type
malfunction
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Event Description
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A user facility area technology operations manager (atom) reported a blood leak occurred between the combiset bloodlines near the arterial transducer connection to the thicker tubing for blood pump.The leak was visually observed and a separated connection caused a leak from the pump wheel door.The leak was noticed approximately 1 hour 49 minutes into treatment.There were no loose connections detected at the time and connections were tested prior to treatment.There was no damage or defect seen on the combiset.When the leak was noticed, the treatment was discontinued.The patient¿s estimated blood loss (ebl) was approximately 700 ml.The patient experienced a loss of consciousness after blood loss, however the patient regained consciousness and then vomited once after the rapid response.A normal saline bolus of 150 ml was administered per standing order.The patient was not admitted to the hospital and returned home that day without medical intervention.The patient was on a fresenius 2008t with bibag machine and using a fresenius dialyzer.There were no changes or a disruption in pressure that could have caused the issue.Additionally, the sample has been discarded and is not available to be returned to the manufacturer for physical evaluation.
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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 area technology operations manager (atom) reported a blood leak occurred between the combiset bloodlines near the arterial transducer connection to the thicker tubing for blood pump.The leak was visually observed and a separated connection caused a leak from the pump wheel door.The leak was noticed approximately 1 hour 49 minutes into treatment.There were no loose connections detected at the time and connections were tested prior to treatment.There was no damage or defect seen on the combiset.When the leak was noticed, the treatment was discontinued.The patient¿s estimated blood loss (ebl) was approximately 700 ml.The patient experienced a loss of consciousness after blood loss, however the patient regained consciousness and then vomited once after the rapid response.A normal saline bolus of 150 ml was administered per standing order.The patient was not admitted to the hospital and returned home that day without medical intervention.The patient was on a fresenius 2008t with bibag machine and using a fresenius dialyzer.There were no changes or a disruption in pressure that could have caused the issue.Additionally, the sample has been discarded and is not available to be returned to the manufacturer for physical evaluation.
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not performed by a fresenius field service technician (fst).Additionally, the serial number for the machine was not provided, preventing a device history record (dhr) review from being performed.The investigation into the cause of the reported problem was not able to be confirmed.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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