The peritoneal dialysis patient's husband called technical support and reported that the patient's tubing set had detached from her catheter during treatment, so the work up during the night and noticed the bed was soaked.The patient reported that part of the blue pin connector was found lying on the floor.The patient received prophylactic antibiotics, her effluent remained clear, and she felt fine.
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The actual device was not returned to the mfr for physical eval; however, a companion sample from the same lot was returned for investigation and no defects were noted.In addition, an investigation of the device mfg records was conducted by the mfr.There were no deviations or non-conformances during the mfg process.In addition, the batch record review confirmed the labeling, material, and process controls were within spec.
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