CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Model Number 2008T HEMODIALYSIS |
Device Problems
Partial Blockage (1065); Fluid/Blood Leak (1250); Cut In Material (2454)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Cramp(s) (2193); Blood Loss (2597)
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Event Date 08/05/2017 |
Event Type
Injury
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Manufacturer Narrative
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A supplemental medwatch report will be submitted upon completion of the investigation.
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Event Description
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An area technical operations manager (atom) reported a hansen hose at the back of a 2008t machine was being cut by the base clamp.The atom reported the hansen line was repaired so the machine could be disinfected each night.Parts were not replaced or repaired.The incident occurred while a patient was in treatment and treatment was ended.Additional follow-up was made with the clinic manager, who stated the patient was removed from the machine and was given extra fluids until the patient was stabilized.The patient complained of leg pain and was sent to have an mri done.Additional patient information and patient condition was unknown.Additional information and medical records were requested.
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Manufacturer Narrative
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Conclusion: a temporal relationship between the leaking arterial hansen hose in the back of the 2008t machine; reported ultrafiltration of 4 kg removed; and the clotted extracorporeal circuit (fresenius combi-set bloodline and optiflux 180nre dialyzer) and the patient¿s symptoms of hypotension, cramping, nausea during hd treatment with an estimated blood loss of 200 cc exists.The 2008t machine operator¿s manual advises to discontinue dialysis/use of the 2008 t machine when a fluid leak is detected as it can result in excessive fluid removal from the patient leading to serious injury or death.Results of the 2008t machine product investigation is not available at the time of this clinical investigation.Therefore, based on the available information in the file the 2008t machine cannot be excluded as a possible causal or contributory factor in this adverse event.A supplemental medwatch report will be submitted upon completion of the investigation.
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Event Description
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On (b)(6) 2017, this patient on renal replacement therapy (rrt) was receiving hemodialysis (hd) treatment via a 2008t machine (using fresenius combi-set bloodline and optiflux 180nre dialyzer) with a pre-treatment weight noted at 125.1 kilograms (kg) and an ultrafiltration goal programmed for 1600 milliliters(ml).Approximately, one hour into hd treatment the patient reported feeling ¿funny¿ with complaints of nausea, cramping (in both lower extremities) and became hypotensive (systolic blood pressure (bp) reading in the 90¿s millimeter of mercury (mm/hg).Concomitantly, it was discovered the arterial hansen hose in the back of the 2008 t machine was ¿cut¿ by the base clamp (reportedly coming from the factory overtightened) and leaking in the rear of the machine.At the same time, the 2008t machine reportedly alarmed high transmembrane pressure (tmp) and patient¿s extracorporeal circuit was observed to be clotted.As a result, the patient was not able to be reinfused his blood in the extracorporeal circuit and the patient lost approximately 200 cubic centimeters (cc) of blood.Furthermore, it was alleged the 2008 t machine removed 4 kg¿s from the patient (in one hour of hd treatment) and the patient¿s weight was approximately (b)(6) when symptoms began.The patient¿s head was lowered and the patient was administered a total of 600 ml of normal saline (in two 300 ml bolus doses).The patient¿s systolic bp improved to 120 mm/hg).The patient¿s treatment was ended (unknown if all of pt.Blood in circuit returned) and the patient was bp was stabilized (unknown blood pressure) and cramping resolved (after approximately one hour).The patient¿s post weight was reportedly (b)(6) and the patient was discharged home.However, later that night the patient reported experiencing leg pain.It was reported the patient did not experience the leg pain prior to the incident and the patient underwent magnetic resonance imagining (mri) on an unknown date (unknown results).Observation of the 2008 t machine (after the incident) indicated that the machine reading indicated a total of 449 ml was removed during the patient¿s treatment.Subsequently, the machine was pulled from service pending further investigation.It was reported the hansen hose was repaired to allow for disinfection of the machine pending investigation.
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Manufacturer Narrative
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The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.
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Event Description
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On (b)(6) 2017, this patient on renal replacement therapy (rrt) was receiving hemodialysis (hd) treatment via a 2008t machine (using fresenius combi-set bloodline and optiflux 180nre dialyzer) with a pre-treatment weight noted at 125.1 kilograms (kg) and an ultrafiltration goal programmed for 1600 milliliters(ml).Approximately, one hour into hd treatment the patient reported feeling ¿funny¿ with complaints of nausea, cramping (in both lower extremities) and became hypotensive (systolic blood pressure (bp) reading in the 90¿s millimeter of mercury (mm/hg).Concomitantly, it was discovered the arterial hansen hose in the back of the 2008 t machine was ¿cut¿ by the base clamp (reportedly coming from the factory overtightened) and leaking in the rear of the machine.At the same time, the 2008t machine reportedly alarmed high transmembrane pressure (tmp) and patient¿s extracorporeal circuit was observed to be clotted.As a result, the patient was not able to be reinfused his blood in the extracorporeal circuit and the patient lost approximately 200 cubic centimeters (cc) of blood.Furthermore, it was alleged the 2008 t machine removed 4 kg¿s from the patient (in one hour of hd treatment) and the patient¿s weight was approximately 121 kg¿s when symptoms began.The patient¿s head was lowered and the patient was administered a total of 600 ml of normal saline (in two 300 ml bolus doses).The patient¿s systolic bp improved to 120 mm/hg).The patient¿s treatment was ended (unknown if all of pt.Blood in circuit returned) and the patient was bp was stabilized (unknown blood pressure) and cramping resolved (after approximately one hour).The patient¿s post weight was reportedly 125.6 kg and the patient was discharged home.However, later that night the patient reported experiencing leg pain.It was reported the patient did not experience the leg pain prior to the incident and the patient underwent magnetic resonance imagining (mri) on an unknown date (unknown results).Observation of the 2008 t machine (after the incident) indicated that the machine reading indicated a total of 449 ml was removed during the patient¿s treatment.Subsequently, the machine was pulled from service pending further investigation.It was reported the hansen hose was repaired to allow for disinfection of the machine pending investigation.
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