Model Number MC+SDX01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Convulsion/Seizure (4406)
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Event Date 04/19/2022 |
Event Type
Injury
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Event Description
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58 minutes into a two-hour dialysis treatment the affected patient started vomiting and subsequently had a witnessed grand-mal seizure.This lasted 1-2 minutes and then subsided.The treatment was ended with a total of 489 ml uf(ultrafiltration).Ems was dispatched and by the time they arrived in the facility the patient was fully conscious and recovered from the event.The nurse noted that there was no change in vital signs before the event, and no indication to her that there was an impending event.This patient is an established dialysis patient with no history of seizures.Per the nurse, after the event the patients blood pressure was slightly elevated, but within normal range.The patient was taken to the hospital and cleared to return back to the nursing home that same day.The patient received dialysis treatments wednesday (b)(6) 2022, thursday (b)(6) 2022 and friday (b)(6) 2022 with no adverse events.(b)(6) 2022: rn said patient dialyzed with no issues.Patient had history of stroke but no history of seizures.Per nurse, no medications were given during the treatment when the event happened, and no new medication was started.Patient has cvc but had avf surgery (b)(6) 2022.Vital signs: pre tx: bp = 103/48, pulse = 90, temp = 97.5, rr = 20 start of tx: bp = 137/67, p = 81 during the event: bp = 142/119, p = 81 post tx: 175/76, p = 95, temp = 96.2, rr = 22 edw: 100.5 kg.Pt came with 100.8 kg but has been losing weight and they have had to change edw for several times for over a month.Nurse informed the team that patient had been losing weight and is on dietary evaluation.Other devices used during event:: nipro elisio 15h: dd+elisio-15h - lot # 21j14f nipro blood tubing set: bl+a430/v912, lot# 20f15 citric acid: ac -200 - nurse was not sure what was the lot # used during the treatment.Following lot #s in the unit: n2b009, n2b007 and n1h007.
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Manufacturer Narrative
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Serial number reported in initial submission was incorrect.Revised section d4 to reflect the correct machine serial number.
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Event Description
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58 minutes into a two-hour dialysis treatment the affected patient started vomiting and subsequently had a witnessed grand-mal seizure.This lasted 1-2 minutes and then subsided.The treatment was ended with a total of 489 ml uf(ultrafiltration).Ems was dispatched and by the time they arrived in the facility the patient was fully conscious and recovered from the event.The nurse noted that there was no change in vital signs before the event, and no indication to her that there was an impending event.This patient is an established dialysis patient with no history of seizures.Per the nurse, after the event the patients blood pressure was slightly elevated, but within normal range.The patient was taken to the hospital and cleared to return back to the nursing home that same day.The patient received dialysis treatments (b)(6) with no adverse events.(b)(6) 2022: rn said patient dialyzed with no issues.Patient had history of stroke but no history of seizures.Per nurse, no medications were given during the treatment when the event happened, and no new medication was started.Patient has cvc but had avf surgery (b)(6) 2022.Vital signs: pre tx: bp = 103/48, pulse = 90, temp = 97.5, rr = 20 start of tx: bp = 137/67, p = 81 during the event: bp = 142/119, p = 81 post tx: 175/76, p = 95, temp = 96.2, rr = 22 edw: 100.5 kg.Pt came with 100.8 kg but has been losing weight and they have had to change edw for several times for over a month.Nurse informed the team that patient had been losing weight and is on dietary evaluation.Other devices used during event:: nipro elisio 15h: dd+elisio-15h - lot # 21j14f nipro blood tubing set: bl+a430/v912, lot# 20f15 citric acid: ac -200 - nurse was not sure what was the lot # used during the treatment.Following lot #s in the unit: n2b009, n2b007 and n1h007.
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Search Alerts/Recalls
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