Description of Event or Problem · 1
BALLOON PUMP ALARM NOTED: "NO GAS" AND NOTED TO NOT BE INFLATING. ALL CONNECTIONS SECURE, NO EXTERNAL EVIDENCE OF LEAKAGE. RN AND CHARGE RN AT BEDSIDE. MD TO BEDSIDE AND REQUESTED ANOTHER BALLOON FOR EXCHANGE OF DEVICE. UPON REMOVAL OF PREVIOUSLY IMPLANTED BALLOON, NOTED TO HAVE LARGE HOLE. BALLOON PLACED IN BIOHAZARD BAD AND SAVED AS EVIDENCE OF EQUIPMENT FAILURE. PT REMAINED GENERALLY HEMODYNAMICALLY STABLE, ALTHOUGH THERE WAS A SIGNIFICANT DROP IN SBP WHILE BALLOON OUT. PT REQUIRED EMERGENT BEDSIDE SURGERY TO REPAIR FEMORAL ARTERY. PATIENT A IS A (B)(6) YEAR-OLD LADY WITH NO PREVIOUS CARDIAC HISTORY. SHE PRESENT TODAY FOR CHEST DISCOMFORT, DYSPNEA ON EXERTION. SHE STARTED NOTICING DYSPNEA EXERTION, CHEST DISCOMFORT WHEN SHE WAS WALKING AROUND 1 WEEK AGO. DENIES RESTING SYMPTOMS. NO ORTHOPNEA, NO PND, NO PRESYNCOPE OR SYNCOPE. SHE WENT TO SEE HER PCP EARLIER TODAY AS SCHEDULED. AN EKG WAS DONE, WHICH WAS CONCERNING FOR ACUTE CORONARY SYNDROME. SHE WAS SENT TO EMERGENCY ROOM IMMEDIATELY. SHE IS RESTING WITHOUT DISTRESS WHEN I SAW HER. NO CHEST PAIN, NO CHEST PRESSURE, NO ORTHOPNEA, NO PND. HER EKG SHOWED ST DEPRESSION, BUT NO INDICATION OF STEMI. SHE HAS BEEN HEMODYNAMICS STABLE. TROPONIN IS MILDLY ELEVATED. FDA SAFETY REPORT ID #: (B)(4).