A hemodialysis inpatient user facility reported that during treatment, a blood leak occurred due to a crack in the dialyzer.The leak was visually observed coming from the crack of the top of the dialyzer.Estimated blood loss was 100cc's.Pt had no adverse effects.Sample is not available, sample was discarded.
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The device was not returned to the mfr for physical eval and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the mfr.There were no deviations or nonconformances during the mfg process.In addition, the batch record review confirmed the labeling, material, and process controls, were within spec.
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