Catalog Number RTLR180111 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Electrolyte Imbalance (2196)
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Event Date 06/11/2017 |
Event Type
Injury
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Manufacturer Narrative
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A follow up mdr will be submitted upon completion of the plant's investigation.
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Event Description
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A peritoneal dialysis patient called tech services to find out where her replacement cycler was.The patient reported that she was in the hospital for two weeks and just got home.Follow up information was received from the patient's nurse.The nurse reported that the patient was admitted to the hospital for hyperkalemia following a dialysis "strike".The nurse reported that the patient stopped doing her peritoneal dialysis on (b)(6) 2017 which led to the patient being admitted to the hospital.The patient had informed the nurse that she would not do dialysis due to having a refurbished machine that alarms.The patient was offered a replacement cycler, but declined.The patient was also instructed to call tech services to discuss the alarms, but she also refused to do this.The patient received a new cycler upon discharge from the hospital.The patient's nurse reported that she set the patient's cycler up when the new one was delivered.The patient was noted to be non compliant with therapy.
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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 nonconformances during the manufacturing process.There is no documentation in the complaint file to support a temporal or causal association between the liberty cycler and the patient experiencing hyperkalemia requiring subsequent hospitalization.The patient¿s adverse event is attributed to patient non-compliance (declining to perform dialysis treatments at home) beginning 9 days prior to the hospitalization event.
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Search Alerts/Recalls
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