Catalog Number RTLR180111 |
Device Problems
Invalid Sensing (2293); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Seizures (2063)
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Event Date 05/16/2015 |
Event Type
Injury
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Event Description
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A peritoneal dialysis (pd) pt reported that she had convolutions while in treatment during drain zero and contacted 911.The pt stated that she did not know if the convolutions were cycler related.The following is based on the medical records received from the pt's treatment facility.The pt presented to the emergency department with two acute seizure episodes earlier in the day.The pt was confused and not able to give a good history.The pt was able to state she had a headache earlier in the day and had a seizure that resolved spontaneously.While she was enroute to the hospital she had a generalized seizure that also resolved spontaneously.The pt was severely hypertensive with systolic blood pressure of 227.The acute seizures were considered to be likely secondary to the hypertensive emergency, but posterior reversible encephalopathy syndrome needs to be ruled out.The pt was able to do alternative treatment at the hospital.On (b)(6) 2015 vitals: blood pressure 226/98, pulse rate 76 beats per minute, respiratory rate: 24 breaths per minute, oxygen saturation: 90 percent on room air.
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Manufacturer Narrative
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This report is being submitted as part of a system level review; which will include an investigation of all potential fresenius products being used at the time of the event.A supplemental report will be submitted upon completion of plant's investigation and clinical investigation of medical records.
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Manufacturer Narrative
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A return product investigation was not performed as the cycler was not replaced for the reported symptoms.Field service investigation is not performed on cyclers the batch records confirmed that released product met specifications; and documented manufacturing process controls were within specification.The system level review of the liberty cycler and concomitant products found no indication that the products caused or contributed in any way to the patient event.Medical records concluding summary of findings as event related to fresenius products(s): on (b)(6) 2015, it was noted that the patient can be discharged from nephrology standpoint.The patient's blood systolic blood pressure was 200 on (b)(6) 2015 and 160 on (b)(6) 2015 not optimally controlled still.Blood pressure medications were being adjusted for this.Based on records, the patient's seizures seem to be related to uncontrolled hypertension not any of fmc products it is unlikely this event was related to fmc product use.
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Search Alerts/Recalls
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