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The system was used for treatment.A batch record review of kit lot e132 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.(b)(4) lot# ae3037 (manufacture date: 06/17/2015 and expiration date: 05/31/2018) was reviewed.No trends or nonconformances related to the complaint were noted.The lot met release requirements.Trends were reviewed for complaint categories, fainting/fall and seizure.No trends were detected for these complaint categories.From a device perspective, the ecp treatment was completed normally with no problems or alarms.However, since the ecp treatment could not be ruled out as a contributory cause of the event; this case will be reported as a mdr out of an abundance of caution.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Adverse event terms: fall and seizure.(b)(4).Device not returned to manufacturer.
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The customer reported that a patient who had just started extracorporeal photopheresis (ecp) treatments, had an accident during the night after his first treatment.The customer stated that the patient fell and then experienced an epileptic seizure.The customer reported that the patient was admitted to the intensive care unit.The customer stated that the patient's ecp procedure was completed normally with no problems or alarms.On october 27, 2016, the patient's treating physician reported that the patient's ecp procedure was completed on (b)(6) 2016 around 12:00, noon.The physician stated that the patient's "fall", given that it was accompanied with urine loss, was more likely an epileptic seizure.The physician reported that the seizure took place on (b)(6) 2016 around 6:00 am.The physician stated that the patient was asleep in the hours before the "fall", and that there were no reports of any unusual observations.The physician reported that the patient did not experience any unusual symptoms during his ecp treatment.The physician stated that the patient did not suffer an external head injury when he "fell".The physician reported that the patient experienced only bruising on the back of his head.The physician reported that, most likely, the fall was the result of an epileptic attack, and the patient's next clinically clear epileptic attack occurred around 7:45 am.The physician stated that the patient did not have a history of epileptic seizures.The physician reported that the patient's first two seizures stopped spontaneously, however at 8:15 am the patient experienced a third tonic-clonic seizure and r/diazepam vv was administered to the patient.The physician stated that the patient was transferred to the intensive care unit, and after arriving at the intensive care unit the patient experienced two more epileptic seizures.The physician reported that on (b)(6) 2016 after the patient's first epileptic seizure a ct scan of the patient's brain was performed and there was no evidence of an intracranial hemorrhage.The physician stated that after the patient's third seizure, an mri of the patient's brain was performed and the results indicated diffused cortical edema, compatible with posterior reversible encephalopathy syndrome (press).The physician also reported that the patient underwent a lumbar puncture and the results were normal.The physician stated that the patient was treated with acute diazepam, followed by levetiracetam and valproate for the seizures.The physician reported that the patient stopped taking the medications ciclosporin and voriconazole, and started taking mycophenolate.The physician stated that the patient continued taking amoxyclavulaanzuur and was also given magnesium supplements and a phosphate iv.The physician reported that after (b)(6) 2016, no new seizures occurred, and that the patient was neurologically fully recovered.The physician stated that after optimizing the patient's medications due to corticoid induced hyperglycemia, the patient was expected to be discharged on either (b)(6) 2016.The physician reported that, most likely, the patient's seizures and press were due to the patient's dosage of cyclosporine.However, the physician stated that he could not exclude that either electrolyte fluctuations or an altered fluid balance could have also provoked the symptomatology.The physician reported that the patient exhibited a decrease in his total calcium, and although the patient was diagnosed with extreme hypoproteinemia there were no complaints, even during his ecp treatment, that would have indicated functional hypocalcemia.The physician stated the patient's magnesium levels were relatively low and iv magnesium supplements were administered immediately when the patient arrived in the intensive care unit.The physician reported that there was clear evidence of hypophosphatemia (0.85 mmol / l on the morning before the ecp and 0.64 mmol / l on the day after [normal range 1 to 1.65 mmol / l]) and iv phosphate was also administered to the patient.The physician stated that the patient exhibited significant polyuria in the first 24 hours after his admission to the intensive care unit.The patient's hematologist was also consulted.The patient's hematologist reported that he fully endorsed the treating physician's evaluation of this patient's case.The hematologist stated that the only addition that he would add to the patient's evaluation was that the patient's voriconazole (vfend) level was toxic and this medication was stopped on (b)(6) 2016, the day before the seizures.The hematologist also reported that he agreed that the patient's cyclosporine level was too high and the drug's dose had been sequentially tapered, two days before the event.The hematologist stated that the seizures still occurred despite this pause/dose reduction, thus the doctor believed that this was a multifactorial problem with the press being the main cause.The hematologist reported that the patient's electrolyte disturbances likely reduced the patient's seizure threshold.On (b)(6) 2016, the customer stated that the patient was discharged in good general condition on (b)(6) 2016.The customer reported that the patient has since completed two problem-free ecp cycles ((b)(6) 2016).The customer stated that the patient still receives keppra for the prevention of epilepsy and the medication neoral (which was the triggering factor) has been switched to cellcept.The customer reported that the patient's corticoids have also been tapered down from 32mg to 24 mg.The kit was not returned for investigation as it had already been discarded.
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