Description of Event or Problem · 1
DEVICE NOT WORKING AS EXPECTED, NO USER ERROR. DURING NEUROSURGICAL CRANIOTOMY CASE THE IRRIGATING BIPOLAR TUBING BEGAN MALFUNCTIONING AND LEAKING HEAVILY STERILE IV NACL FROM THE AREA NEAR THE IV SOLUTION SPIKE AREA (WHITE IN COLOR). THE IRRIGATION BIPOLAR TUBING CAME FROM THE STERILE CRANIOTOMY PACK EXP DATE 10/01/2016, MFG DATE 03/30/2015, LOT# 34538, CATALOG SNE51CNRWS. THEREFORE, THE SURGEON WAS NOTIFIED AND ANOTHER STERILE IRRIGATING BIPOLAR SET WAS OPENED AND THIS TIME THE TUBING THAT IS THREADED AROUND THE TURNING WHEEL MALFUNCTIONED AND CAME LOOSE THEN STERILE IV NACL SPILLED ALL OVER THE FLOOR. THE BIPOLAR TUBING ITEM WAS KIRWAN SURGICAL PRODUCTS LLC REF#:10-4601, LOT# 021715, EXP 2020-02. ONCE AGAIN THE STERILE TUBING WAS REPLACED. HOWEVER, STERILE SUTURE TIES HAD TO BE TIED TO SECURE AND REINFORCE THE TUBING AROUND THE WHITE RUBBER TUBING TO PREVENT IT FROM LEAKING PRIOR TO THREADING TUBING IN THE BIPOLAR DEVICE. THE SURGERY CONTINUED WITHOUT FURTHER PROBLEMS WITH THE IRRIGATING BIPOLAR TUBING. CHARGE NURSE NOTIFIED REGARDING ISSUES WITH BIPOLAR TUBING PACKAGES AND TUBING GIVEN TO CHARGE NURSE AFTER END OF CASE. NEURO SURGEON NOTIFIED.