Information was received regarding a cadd cassette reservoir.It was reported that it was impossible to operate the patient controlled analgesis, pca, with the cassette.There was no issue with the pump used.A cassette from a different lot resolved the issue.There was no patient, or clinician injury associated with this occurrence.No further details provided at this time.
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Other, other text: additional information h6, h10.This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.No problems or issues were identified during the device history record review.Six samples were received in unused conditions with its original packaging and one sample was received in used conditions without its original packaging, decontaminated and inside in plastic bag.Visual inspection was performed at 12 to 16 inches under normal conditions of illumination.The used sample received was found without blue clip and with pressure plate damaged.During the functional testing, the samples were fully primed and connected without difficulty, the pump was set running and no alarms were activated.The complaint was not confirmed.The root cause was unable to be determined.No actions taken were performed since the complaint was not confirmed.E4 was unknown, corrected data: d1.
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