[18442705]
A premature twin born 6/17/92 remained in hospital until 10/12/92. On 10/15 he was brought to the clinic in respiratory failure; admitted to peds icu. Tube feedings were ordered soon after admission on 2/1/93, the gastrostomy tube fell out the required changing. The nurse/doctor reinserted the tube instilling at least 9cc/water into the balloon to inflate it. The feeding was resumed at 40cc/hr. The baby was fussy all night; and found at 0720 on 2/2 with a severely distended abodomen and poor vital signs. He was taken to surgery at 1115 for two perforations of the small intestines. Subsequently he developed multiple complications including sepsis. He was discharged on a ventilator with home care services. 6/16/93. A meeting with the sales representative took place on 5/11/93 with corrective actions suggested. Device labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: a device from same lot was evaluated. Results of evaluation: labeling - incorrect instructions for use, incorrect technique/procedure. Conclusion: device failure directly caused event, user error contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5