[16298297]
During a surgical procedure to repair a meniscus tear of the right knee, the arthroscopic pump alarms did not activate, failing to alert the physician to increased presure in the anterior thigh. A rupture of the supra-patella pouch allowed extravasation of fluid into the submuscular potential space creating a compartment syndrome of the right thigh. An anterior thigh comjpartment relaease was performed. The physician elected to delay the planned anterior cruciate ligament reconstruction. It was done 4/13/92. The patient was dismissed from the hospital on 4/15/92. The arthroscopic pump was performance tested by the facility's bio-medical engineering department. The event could not be duplicateddevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: none or unknown. Conclusion: device evaluated and alleged failure could not be duplicated, no failure detected and product within specification, none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5