|
|
| Catalog Number RTLR180111 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Death (1802); Encephalopathy (1833); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Sepsis (2067); Septic Shock (2068); Suffocation (2088); Urinary Tract Infection (2120); Vomiting (2144); Extubate (2402); Respiratory Failure (2484); Confusion/ Disorientation (2553); Hypervolemia (2664)
|
| Event Date 06/02/2017 |
|
Event Type
Death
|
|
Manufacturer Narrative
|
|
A supplemental medwatch report will be submitted upon completion of the investigation.
|
| |
|
Event Description
|
|
A peritoneal dialysis (pd) patient's clinic registered nurse (rn) reported the pd patient had been hospitalized on (b)(6) 2017 due to nausea, vomiting and refusal to eat, and expired on (b)(6) 2017 while hospitalized due to septic shock.Additional information and medical records were requested.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Event Description
|
|
A peritoneal dialysis (pd) patient's clinic registered nurse (rn) reported the pd patient had been hospitalized on (b)(6) 2017 due to nausea, vomiting and refusal to eat, and expired on (b)(6) 2017 while hospitalized due to septic shock.Additional information and medical records were requested.
|
| |
|
Event Description
|
|
Medical records and completed end stage renal disease (esrd) death notification form were reviewed.This esrd patient on peritoneal dialysis (pd) therapy was followed by her own nephrologist and developed significant nausea/altered mental status and transferred from extended care facility to the hospital on (b)(6) 2017 for evaluation, hospital admission and subsequent intensive care critical care management with patient expiration on (b)(6) 2017.A follow call to the peritoneal dialysis registered nurse (pdrn) revealed the patient's spouse reported the patient expired.Review of the esrd death notification form and medical records revealed the patient was in the hospital and on continuous cycler-assisted peritoneal dialysis (ccpd) therapy.The primary cause of death was septicemia and renal replacement therapy (rrt) was discontinued after patient/family requested to stop dialysis.On (b)(6) 2017 prior to admission (pta) in the extended care facility (ecf), the patient received a last of antibiotic treatment with vancomycin for clostridia difficile.The night before the husband had seen patient and noted she was conversant.In the morning of (b)(6) 2017 the patient¿s mental status found to be very altered and noted the ¿patient was being given frequent doses of valium and percocet at the ecf.¿ on (b)(6) 2017 the patient urgently admitted experiencing nausea and was admitted via hospitalist service with urgent transfer to intensive care unit (icu) with significant fluid restriction secondary to heart failure.The patient was treated with ceftriaxone for urinary tract infection and received 2 liters of normal saline iv.The patient appeared increasingly quite somnolent with significant hypotension and received additional one liter of normal saline, vancomycin 2760 milligrams (mg), gentamycin 200 and naran intravenous (i.V.) push 0.4 mgm single dose for narcotic/opioid reversal.The hospital course noted the patient was given 4 liters of iv fluid on admission, which improved blood pressure slightly and still required treatment with pressors.Fluid resuscitation was done.At the end of comprehensive critical icu care, the patient required a total of 6 pressors.The physician team identified the likely sources of infection were: biliary, abdominal ultrasound performed and positive for cholelithiasis with mild gallbladder thickening.Family members agreed to consent to insertion of a central venous line.The patient started regaining alertness, waking up responding to verbal commands and blood pressure increased to systolic reading: 100.During the hospital course the patient developed septic shock, acute respiratory failure requiring intubation and mechanical ventilation, lactic acidosis, altered mental status up to an including progressive somnolence, mental status decompensation which was likely secondary to septic encephalopathy, potential overuse of valium and percocet at the ecf) non-st-elevation myocardial infarction.During hospital course there were serial and frequent evaluation of elevated troponin levels without electrocardiogram changes noted.No acute intervention was recommended.Nephrology was following the patient ordering pd therapy and in the end patient was receiving intensified pd treatments 4 times a day with unknown response to pd treatment.The patient, due to altered mental status early in admission, clearly stated to multiple physicians she did not want aggressive measures but after the patient¿s altered mental status and became alert changed her mind and husband ¿stated she told him that she changed her mind¿ and was intubated and placed on mechanical ventilation.The patient was made a code c by the family members and 1.5 hours before expiring the patient was extubated and expired 30 minutes post extubation on (b)(6) 2017 in the hospital.Discharge diagnoses were septic shock, acute hypoxemic respiratory failure (ahhrf), altered mental status (ams).
|
| |
|
Manufacturer Narrative
|
|
Date of event: (b)(6).Conclusion: this patient expired after a complex urgent er visit directly from an extended care facility with significant nausea and altered mental status, subsequent hospitalization with direct transfer to the icu experiencing nausea, fluid overload, increasing somnolence and severe hypotension with attempted 4 liters of fluid to increase blood pressors, with minimal effect.The patient required pressor treatments with 6 different types of medications administered, antibiotics for positive urinary tract infection (uti) administration of narcan to reverse possible opioid/ sedative overdose from ecf.Patient regained consciousness and was alert for a very brief period of time, then decompensated requiring the patient to be intubated for short period of time at family and patient request.Nephrology following the patient escalated pd therapy and ordered four times a day in attempt to correct fluid overload.Patient had a highly complex acute comorbidities which may have been contributory to the patient¿s subsequent expiration but additionally the complaint file contains multifactorial complexities.The patient¿s discharge diagnosis at time of expiration probably causal and contributory are: septic shock, acute hypoxic respiratory failure requiring intubation and mechanical ventilation, progressively elevated lactic acidosis most likely secondary to bowel ischemia in the setting of 6 pressors administered in icu, altered mental status most likely cause secondary to septic encephalopathy, multi organ failure(mof).
|
| |
|
Event Description
|
|
Medical records and completed end stage renal disease (esrd) death notification form were reviewed.This esrd patient on peritoneal dialysis (pd) therapy was followed by her own nephrologist and developed significant nausea/altered mental status and transferred from extended care facility to the hospital on (b)(6) for evaluation, hospital admission and subsequent intensive care critical care management with patient expiration on 06/02/2017.A follow call to the peritoneal dialysis registered nurse (pdrn) revealed the patient's spouse reported the patient expired.Review of the esrd death notification form and medical records revealed the patient was in the hospital and on continuous cycler-assisted peritoneal dialysis (ccpd) therapy.The primary cause of death was septicemia and renal replacement therapy (rrt) was discontinued after patient/family requested to stop dialysis.On (b)(6) prior to admission (pta) in the extended care facility (ecf), the patient received a last of antibiotic treatment with vancomycin for clostridia difficle.The night before the husband had seen patient and noted she was conversant.In the morning of (b)(6) the patient¿s mental status found to be very altered and noted the ¿patient was being given frequent doses of valium and percocet at the ecf.¿ on (b)(6) the patient urgently admitted experiencing nausea and was admitted via hospitalist service with urgent transfer to intensive care unit (icu) with significant fluid restriction secondary to heart failure.The patient was treated with ceftriaxone for urinary tract infection and received 2 liters of normal saline iv.The patient appeared increasingly quite somnolent with significant hypotension and received additional one liter of normal saline, vancomycin 2760 milligrams (mg), gentamycin 200 and naran intravenous (i.V.) push 0.4 mgm single dose for narcotic/opioid reversal.The hospital course noted the patient was given 4 liters of iv fluid on admission, which improved blood pressure slightly and still required treatment with pressors.Fluid resuscitation was done.At the end of comprehensive critical icu care, the patient required a total of 6 pressors.The physician team identified the likely sources of infection were: biliary, abdominal ultrasound performed and positive for cholelithiasis with mild gallbladder thickening.Family members agreed to consent to insertion of a central venous line.The patient started regaining alertness, waking up responding to verbal commands and blood pressure increased to systolic reading: 100.During the hospital course the patient developed septic shock, acute respiratory failure requiring intubation and mechanical ventilation, lactic acidosis, altered mental status up to an including progressive somnolence, mental status decompensation which was likely secondary to septic encephalopathy, potential overuse of valium and percocet at the ecf) non-st-elevation myocardial infarction.During hospital course there were serial and frequent evaluation of elevated troponin levels without electrocardiogram changes noted.No acute intervention was recommended.Nephrology was following the patient ordering pd therapy and in the end patient was receiving intensified pd treatments 4 times a day with unknown response to pd treatment.The patient, due to altered mental status early in admission, clearly stated to multiple physicians she did not want aggressive measures but after the patient¿s altered mental status and became alert changed her mind and husband ¿stated she told him that she changed her mind¿ and was intubated and placed on mechanical ventilation.The patient was made a code c by the family members and 1.5 hours before expiring the patient was extubated and expired 30 minutes post extubation on (b)(6) in the hospital.Discharge diagnoses were septic shock, acute hypoxemic respiratory failure (ahhrf), altered mental status (ams).
|
| |
|
Search Alerts/Recalls
|
|
|
