[73]
Infant sustained blisters on bottom of feet and left hand. One blister with dark, possibly necrotic base onplantar surface near mid sole on each foot, and similar blister on palm of left hand, a little ulnar from mid palm. These were nearly circular. Etiology of the lesions is uncertain at this time, suspect thermal burns from fiber transiluminator. Infant had been on vi antibodies and had iv started using transilluminator on 12/25/91. Red marks wre first noted on hand and feet the following morning. Since that time, these marks have blistered. Md took transilluminator and turned it on. Placed his hand over the end of it and had to remove his hand within 30 seconds due to intense heat from the end of the fiber optics. The transilluminator was dismantled to avoid any further possibility of usage. Spoke with rn who confirmed that transilluminator was used to start iv. Transilluminator was picked up by biomedical electronic for evaluationdevice not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-nov-90. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device not used as labeled/indended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: storage/shipment. Conclusion: user error caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5