UK MHRA has issued a Medical Device Alert (MDA) pertaining to the GEMSTAR™ infusion pump manufactured by Hospira Inc.
The alert follows a Field Safety Notice(FSN) issued in March which reported that the company had received customer reports of bolus delivery failures when using the GEMSTAR bolus cord.
The FSN noted that the Possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the Bolus Cord.
Hospira’s review has determined that the likely root cause is associated with the force applied to remove the bolus cord from the base of the GEMSTAR unit. If excessive force is used to remove the bolus cord, it may result in broken or frayed wiring at the base of the cord.
Potential risk due to failure of the bolus cord is the potenfial for an unrequested bolus delivery or the failure to deliver requested medication to the patient. The amount of unrequested delivery will be limited by programming lockout volumes. An unrequestad narcotic delivery may cause over-sedation requiring possible medical intervention, but is unlikely to result in serious or life threatening injuries. The failure to deliver requested narcotic medication may result in the lack of adequate pain relief.
The MDA requires identification and inspection of affected bolus cords and discontinuation in use of cracked or damaged cords. Users are requested to contact Hospira for a replacement.
Users are required to follow the manufacturer’s instructions for use when removing the bolus cord, routinely checking for physical damage to the cord.
The full MDA can be found here.