Model Number 190713 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Syncope/Fainting (4411)
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Event Date 06/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between hemodialysis utilizing the 2008t machine and the patient event of syncope with subsequent transport to the hospital.There is a possible causal relationship between the reported leak due to the disconnected hose at the air separator on the 2008t machine and the patient¿s syncopal event.There is no information documenting if the patient event occurred prior to the start of the leak or if there were any alarms alerting the operator of a leak.The machine is designed to alert with a high alarm for a fill program alarm.This alerts the operator to inspect for air in the system and correct as required.If the alarm doesn¿t clear the operator is instructed to return the blood to the patient and take the machine out of service.It is unknown if the patient had underlying medical conditions that caused or contributed to the adverse event.Patients undergoing dialysis and experiencing syncope and collapse is not uncommon and is a presenting symptom of an underlying cardiac disease, dysrhythmia, pulmonary hypertension, and intradialytic or postural hypotension.Based on the limited information, the leak due to the disconnected hose at the air separator on the 2008t machine cannot be excluded as causing or contributing to the patient¿s syncopal event.
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Event Description
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A biomedical technician reported that a patient had an incident on 2008t machine during treatment on (b)(6) 2022.The biomed found the machine that had been removed from the treatment floor to have an intense leak coming from the back of the machine.The hose to the bottom of the air separator was not connected to the air separator but hanging.It was later reported that the patient had passed out during the treatment.The patient was transported to the hospital via ambulance.Attempts to obtain additional information were unsuccessful.No further information is known.
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Manufacturer Narrative
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Plant investigation: a user facility field service technician (fst) was called onsite by a user facility to inspect a 2008t machine.The fst found the tubing as off the bottom of the air separator and was leading to the uf pump.The loading pressure regulator was screwed all the way down and the pressure was at 67.1 psi when it¿s supposed to be between 23 and 25 psi.The machine was inoperable with a flow error and was leaking from multiple points.No repairs were done, and the machine is still out of service.Machine functional tests were not completed.There was patient involvement according to the intake.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.A physical investigation was not performed; the product was not returned.Investigation determines that there was causal relationship between the objective evidence (photo) and the alleged event; the alleged event is confirmed.
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Event Description
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A biomedical technician reported that a patient had an incident on 2008t machine during treatment on (b)(6) 2022.The biomed found the machine that had been removed from the treatment floor to have an intense leak coming from the back of the machine.The hose to the bottom of the air separator was not connected to the air separator but hanging.A user facility field service technician (fst) was called onsite by a user facility to inspect the machine.The fst found the tubing as off the bottom of the air separator and was leading to the ultrafiltration (uf) pump.The loading pressure regulator was screwed all the way down and the pressure was at 67.1 pounds per square inch (psi) when it¿s supposed to be between 23 and 25 psi.The machine was inoperable with a flow error and was leaking from multiple points.No repairs were done on 06/08/2022, and the machine remained out of service.Machine functional tests were not completed.It was later reported that the patient had passed out during the treatment.The patient was transported to the hospital via ambulance.Attempts to obtain additional information were unsuccessful.No further information is known.Photos were provided for the investigation.
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).Investigation determines that there was no causal relationship between the objective evidence and the alleged event; the alleged event is unconfirmed.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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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Event Description
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A biomedical technician reported that a patient had an incident on 2008t machine during treatment on (b)(6) 2022.The biomed found the machine that had been removed from the treatment floor to have an intense leak coming from the back of the machine.The hose to the bottom of the air separator was not connected to the air separator but hanging.It was later reported that the patient had passed out during the treatment.The patient was transported to the hospital via ambulance.Attempts to obtain additional information were unsuccessful.No further information is known.
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Event Description
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A biomedical technician reported that a patient had an incident on 2008t machine during treatment on (b)(6) 2022.The biomed found the machine that had been removed from the treatment floor to have an intense leak coming from the back of the machine.The hose to the bottom of the air separator was not connected to the air separator but hanging.A user facility field service technician (fst) was called onsite by a user facility to inspect the machine.The fst found the tubing as off the bottom of the air separator and was leading to the uf pump.The loading pressure regulator was screwed all the way down and the pressure was at 67.1 psi when it¿s supposed to be between 23 and 25 psi.The machine was inoperable with a flow error and was leaking from multiple points.No repairs were done on 06/08/2022, and the machine remained out of service.Machine functional tests were not completed.It was later reported that the patient had passed out during the treatment.The patient was transported to the hospital via ambulance.Attempts to obtain additional information were unsuccessful.No further information is known.
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Manufacturer Narrative
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Information was available and inadvertently omitted from previous reports.Correction: b2, b5, d9, follow-up 1 and follow-up 2 g3 aware date incorrectly set as 07/20/2022 and should have been 06/30/2022, h3, h4 plant investigation: a supplemental mdr will be submitted upon completion of this activity.
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Event Description
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A biomedical technician reported that a patient had an incident on 2008t machine during treatment on (b)(6) 2022.The biomed found the machine that had been removed from the treatment floor to have an intense leak coming from the back of the machine.The hose to the bottom of the air separator was not connected to the air separator but hanging.A user facility field service technician (fst) was called onsite by a user facility to inspect the machine.The fst found the tubing as off the bottom of the air separator and was leading to the ultrafiltration (uf) pump.The loading pressure regulator was screwed all the way down and the pressure was at 67.1 pounds per square inch (psi) when it¿s supposed to be between 23 and 25 psi.The machine was inoperable with a flow error and was leaking from multiple points.No repairs were done on 06/08/2022, and the machine remained out of service.Machine functional tests were not completed.It was later reported that the patient had passed out during the treatment.The patient was transported to the hospital via ambulance.Attempts to obtain additional information were unsuccessful.No further information is known.Photos were provided for the investigation.
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Search Alerts/Recalls
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