BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 3020620 · Received March 21, 2013

    Report

    Report Number
    1219856-2013-00067
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 21, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CALL FROM THE CARDIAC VASCULAR UNIT (CVU) RN TO THE CLINICAL SUPPORT SPECIALIST (CSS) AT 1458 CST THAT THERE WERE TIMING ERRORS WHILE IN AUTOPILOT. INDICATION FOR USE: POST MI, EJECTION FRACTION (EF) 35% AFTER IAB INSERTION, CARDIAC OUTPUT (CO) 5.2/CI 2.5, SYSTEMIC VASCULAR RESISTANCE (SVR) 1170, PULMONARY ARTERY (PA) 35/20, CENTRAL VENOUS PRESSURE (CVP) 8, GTS INCLUDING MILRINONE AT 03.375 MCG/KG/MIN, NEOSYNEPHRINE AT 30, EPI # .03, HEPARIN AND PROPOFOL. INTUBATED, SEDATED, 1:2 ASSIST RATIO. A 40 CC INTRA-AORTIC BALLOON (IAB) WAS INSERTED APPROX 3 DAYS PRIOR TO THE EVENT THROUGH THE LEFT FEMORAL WITH NO ISSUES NOTED. THE RN EXPLAINED THAT THE TIMING LOOKED EARLY ON INFLATION AND LATE ON DEFLATION WHILE IN AUTOPILOT. THE PUMP IS CURRENTLY IN OPERATOR MODE AND HAS BEEN FOR SEVERAL HOURS. THE CSS HAD THE RN FAX THE STRIPS IN AUTOPILOT BEFORE THE RN MADE THE SWITCH TO OPERATOR MODE AND THEN ONE IN OPERATOR MODE. AFTER THE RN SENT THE CSS STRIPS, THE CSS CALLED THE RN BACK AND EXPLAINED THAT DEFLATION ACTUALLY LOOKED LATE AND WE DISCUSSED WHY. THE RN THEN RELAYED THAT THE PUMP HAD BEEN EXPERIENCING HIGH PRESSURE ALARMS SINCE YESTERDAY. THE CSS ASKED IF THE LAST TWO RN'S CARING FOR THE PT HAD PASSED THAT ALONG AS THE CSS HAD NOT BEEN TOLD OF ANY ALARMS IN THE PREVIOUS CALLS. THE RN SAID THAT IT HAD BEEN HAPPENING INTERMITTENTLY EVERY HOUR OR SO. THE RN STATED THAT WHEN THE PT WAS FIRST ADMITTED TO THE UNIT THE PT WAS EXTUBATED, VERY AGITATED AND MOVING AGGRESSIVELY IN BED. THE PUMP HAD MULTIPLE ALARMS AT THAT POINT. THE PT WAS THEN INTUBATED AND HAD BEEN MUCH BETTER OVER THE PAST "COUPLE DAYS" BUT THE PUMP WAS STILL HAVING HIGH PRESSURE ALARMS. THE RN DID CONFIRM FOR THE CSS THAT THERE WAS NO BLOOD IN THE TUBING. THE CSS THEN ASKED THE RN TO DESCRIBE THE BALLOON PRESSURE WAVEFORM (BPW) AND THE RN STATED THAT IT HAD A CHAIR SHAPE. THE CSS THEN ASKED THE RN TO BRING THE CURSOR DOWN ONTO THE "CHAIR" AND RELAY THE PRESSURE READING. THE RN SAID IT WAS ZERO. THE CSS THEN ASKED THE RN TO SEND THE ALARM STRIP AS THE PUMP ALARMED A COUPLE OF TIMES DURING OUR CONVERSATION. AFTER REVIEW, THE CSS EXPLAINED THAT THE IAB SEEMED KINKED OR TOO LARGE FOR THE PT. THE RN DID CONFIRM PLACEMENT VIA CX-RAY (TAKEN EARLIER THAT AM) WITH THE ADVANCED PRACTICE NURSE (APN). THE RN DID CONFIRM THE TIP WAS JUST DISTAL TO THE "AORTIC NOTCH." THE CSS THEN HAD THE RN DECREASE THE VOLUME TO 35 CC (NO CHANGE NOTED IN THE BPW) AND THEN TO 30 CC (NO CHANGE IN THE BPW). WE DISCUSSED HOW THIS IS POSSIBLY AN INTERNAL KINK DUE TO TORTUOSITY OR JUST UNDER THE INSERTION SITE. THE RN STATED DISCUSSING WITH THE DOCTOR AND WILL CALL THE CSS BACK. AT 1141 CST THE CSS CALLED THE RN BACK AND THE RN STATED THAT THEY HAD OPTED TO DISCONTINUE IAB. THE CSS THEN SPOKE TO THE APN WHO STATED THAT THERE HAD BEEN NO VISIBLE KINKING TO THE IAB ONCE REMOVED. THE PT IS STABLE AND BEING SUPPORTED WITH GTTS. THE APN DID STATE THAT THEY HAD DONE AN ULTRASOUND TO THE LEFT FEMORAL AND NOTED A NON-OCCLUSIVE THROMBUS FROM THE LEFT COMMON FEMORAL TO THE ILIAC. THE APN DID STATED THAT THEY HAD ISSUES LIKE THIS (TIMING NOT ALARMS) WITH THE SAME PUMP LAST WEEK AND THE PUMP IS GOING TO BE SENT TO BIOMED (B)(6) MORNING ((B)(6) 2013) TO BE CHECKED OUT. I RECEIVED NO FURTHER CALLS. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A DELAY OR INTERRUPTION IN THERAPY SINCE THEY REMOVED THE IAB. THE PT OUTCOME WAS UNCHANGED THROUGHOUT ALL CALLS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 FROM THE FIELD SERVICE REP (FSR) STATED THE BIOMED HAS CHECKED OUT THE PUMP AND COULD NOT FIND ANYTHING WRONG. THE PUMP IS BACK IN SERVICE. THE FSR REPORTED ON (B)(6) 2013 THAT NO CALLS WERE MADE TO US ABOUT THEM HAVING PROBLEMS THE PRIOR WEEK. AFTER REVIEWING THE STRIPS, THE CSS CALLED THE RN BACK AND DISCUSSED THAT THE TRIGGER CLARITY HAD CAUSED SOME OF THE TIMING ERRORS IN AUTOPILOT HOURS AGO. THE CSS AND RN DISCUSSED HOW THIS CAN AFFECT THE PUMP. DUE TO THE PT HAVING A STABLE ELECTROCARDIOGRAM (EKG) TRACING, THE CSS THEN ASKED THE RN TO PUT THE PUMP BACK INTO AUTOPILOT AND THE RN SAID THE TIMING LOOKED MUCH BETTER AND FELT COMFORTABLE LEAVING IT IN AUTOPILOT. THE CSS GAVE THE RN THE DIRECT NUMBER AND SUGGESTED THE RN PASS ALONG THE DIRECT NUMBER TO THE NIGHT SHIFT. AT 1753 CST THE RN CALLED CSS BACK. THE RN STATED HAVING TIMING ISSUES AGAIN ON DEFLATION AND HAD PLACED THE PUMP BACK INTO OPERATOR. THE RN DID STATE THAT THE EKG WAS DISPLAYING A HIGH ST SEGMENT AND THE CSS SUGGESTED MOVING THE LEADS AROUND TO MINIMIZE THE ST AND ENSURE THE R WAVE TO BE THE LARGEST. THE RN STATED CALLING THE CSS BACK AFTER DOING SO. AT 1833 CST THE RN CALLED THE CSS BACK TO STATE THAT IT HADN'T HELPED TO MOVE THE LEADS AROUND. THE RN STATED THAT WHEN THE PUMP WAS IN AP (ATRIAL PRESSURE) TRIGGER THE TIMING LOOKED "GREAT" WHEN IN AUTOPILOT. THE CSS EXPLAINED STAYING IN AP IN AUTOPILOT, AS LONG AS THE PT STAYS IN A REGULAR RHYTHM. THE CSS AND RN THEN DISCUSSED A FIB TRIGGER AND HOW IT WILL NEED AN EKG TO BENEFIT THE PT IF APPROPRIATE IN AN IRREGULAR RHYTHM. THE RN VERBALIZED UNDERSTANDING AND STATED PASSING ON THE CSS'S CELL NUMBER TO THE NEXT SHIFT. NO CALLS WERE RECEIVED THROUGH THE NIGHT. AT 0745 CST THE CSS RECEIVED A CALL FROM THE HOTLINE FROM THE FIRST SHIFT RN WHO IS NOW CARING FOR THE PT. THE RN WAS CALLING DUE TO "EARLY DEFLATION" TIMING ERRORS AND HIGH PRESSURE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118908 NA INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. AS30478

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MILRINONE| EPI| HEPARIN| PROPOFOL| INTRA-AORTIC BALLOON PUMP| NEOSYNEPHRINE