[1912]
A lab technologist was using the dade/baxter immufuge when a glass vial of blood broke in the centrifuge and glass flew out of the holes in the lid. The glass hit the standing technologist's apron, but did not penetrate any skin. Upon investigation we noted two white retaining clips shattered and another cracked. Glass fragments were ejected through the open slots in the lid and deflected off the plastic cap. Had the tech. Been sitting as would be customery, the fragments would have been at eye level. Unit is being returned to mfg. For further evaluation. Device not labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-sep-91. Service provided by: independent service organization. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, mechanical tests performed, visual examination. Results of evaluation: design, material degradation/deterioration. Conclusion: device failure occurred and was related to event, software/firmware contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: use of all similar devices stopped temporarily, inserviced by biomedical engineering dept. Staff. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5