Catalog Number RTLR180343 |
Device Problem
Device Handling Problem (3265)
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Patient Problems
Fall (1848); Bone Fracture(s) (1870)
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Event Date 08/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between pd therapy on the liberty select cycler with drain lines and the patient event of tripping, falling and breaking an ankle.There is a possible causal relationship between the event and the liberty select cycler and drain lines as the low flow alarm was keeping the patient awake resulting in her moving the cycler from bedside.It is unknown if the patient would have tripped had the cycler not been moved.The fresenius liberty select cycler user¿s guide cautions patients about the tripping hazard of the drain line.Based on the available information, the drain lines cannot be excluded as the cause of the patient fall and broken ankle.
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Event Description
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A peritoneal dialysis (pd) nurse reported that a patient went to the hospital and required surgery after they broke their ankle when they tripped on the liberty cycler set's drain line.The patient was at the end of treatment on (b)(6) 2019 with the liberty select cycler when she got up and tripped over the drain line.The patient¿s cycler kept alarming with low flow alarms which was keeping the patient awake.As a result, the cycler was relocated from the side of the patient¿s bed to the bathroom.The patient had to walk to the bathroom to disconnect from treatment when the tripping incident occurred.The patient was transported via emergency medical services (ems) to the hospital where she was diagnosed with a broken ankle.She was sent home with an appointment to see the surgeon.On (b)(6) 2019 the patient underwent surgery and was kept for 24 hours observation.The patient is home recovering with a boot for her ankle and continues to complete pd treatment on the liberty select cycler.No further information was available.
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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Search Alerts/Recalls
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