FDA Adverse Event Injury Summary report: N

TANDEM HEART PERCUTANEOUS VENTRICULAR ASSIST DEVICE

MDR report key: 1029660 · Received April 14, 2008

Report

Report Number
MW5006268
Event Type
Injury
Date Received
April 14, 2008
Date of Event
February 12, 2008
Report Date
April 14, 2008
Manufacturer
CARDIAC ASSIST, INC.
Product Code
DSQ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MO, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PT WAS ON A TANDEMHEART VENTRICULAR ASSIST DEVICE TO SUPPORT HIS CARDIOGENIC SHOCK. TANDEMHEART WAS PLACED IN 2008. ON FIVE DAYS LATER, PT'S NURSE, NOTICED THAT AN "INFUSION AIR BUBBLE" ALARM WAS SOUNDING. WHEN THE INFUSION TUBING WAS INSPECTED, SMALL BUBBLES OF AIR WERE ENTERING THE INFUSION LINE APPARENTLY AT THE JUNCTION OF THE AIR FILTER AND THE INFUSION TUBING. PROVIDERS STOPPED THE INFUSION AND CLAMPED THE LINE. EVEN WITH THE LINE CLAMPED, PROVIDERS CONTINUED TO NOTICE SMALL AIR BUBBLES APPARENTLY BEING PULLED INTO THE INFUSION LUMEN. PROVIDERS WORKED TOGETHER TO CHANGE THE INFUSION SET PER THE TANDEMHEART CONSOLE'S ON-SCREEN INSTRUCTIONS. WHILE CHANGING THE INFUSION LINE, A "LOW FLOW" ALARM SOUNDED INDICATING FLOWS AS LOW AS ZERO BRIEFLY EVEN THOUGH THE CONSOLE WAS RUNNING THE PUMP AT ITS USUAL 7500 RPM'S. THE TANDEMHEART PUMP DRIVE LINE WAS DISCONNECTED FROM THE CONSOLE FOR ABOUT 10 SECS, THEN RECONNECTED IT AND RE-STARTED THE PUMP. THIS MANEUVER FORCED THE CONSOLE TO SWITCH TO ITS BUILT-IN "SECONDARY" PUMP DRIVE UNIT. PUMP FLOWS STILL LOW -0.4 TO 1.4 L/MIN.- PROVIDERS THEN NOTICED THAT WITH THE PT'S HEIGHT OF BED AT ABOUT 20 DEGREES ELEVATION, THERE WAS "CHATTER" IN THE PUMP INFLOW TUBING -OUTFLOW FROM THE PT-. CHATTER IS A SIGN OF INCOMPLETE FILLING DUE EITHER TO CATHETER MALPOSITION AND/OR LOW VOLUME STATUS. PROVIDERS LOWERED THE HOB TO ALMOST FLAT AND CHATTER IN THE TUBING WAS RELIEVED. PT'S SURGEON ORDERED AN ALBUMIN BOLUS TO ADDRESS THE POSSIBLE LOW FILLING CAUSE OF THE CHATTER. AFTER THE FLUID BOLUS AND THE POSITION CHANGE, THE PUMP RESUMED OPERATION WITH RETURN OF FLOWS TO PREVIOUS LEVELS -2.7 - 3.0 L/MIN WITH PUMP AT 7500 RPM'S-. THERE WERE STILL SMALL AIR BUBBLES IN THE INFUSION TUBING. THE TANDEMHEART INFUSION LUBRICATION LUMEN IS DESIGNED FOR ONE-WAY FLOW -FROM THE INFUSION BAG TO THE PUMP-. ATTEMPTING TO ASPIRATE AIR COULD HARM THE MEMBRANE BETWEEN THE INFUSION SIDE AND THE BLOOD SIDE OF THE PUMP. OUR CONCERN WAS THAT EVEN THOUGH THE PUMP OUTFLOW CANNULA -BACK TO PT- IS SHORT-ENDING AT ABOUT THE BIFURCATION OF THE FEMORAL ARTERY, THE AIR BUBBLES PRESENTED AN UNK BUT POTENTIAL RISK TO THE PT. CALL PLACED TO THE TANDEMHEART 1-800 HELP NUMBER THAT IS POSTED ON THE CONSOLE. THE CLINICIAN AT TANDEMHEART INSTRUCTED PT'S SURGEON TO CUT THE INFUSION LUMEN CLOSE TO THE PUMP SO THAT AIR COULD BE FLUSHED FROM THE LINE. THIS WAS DONE WITH NO PROBLEMS. SURGEON THEN HAD TO RECONSTRUCT THE INFUSION LUMEN USING TWO 14-GAUGE IV CATHETERS IN EACH SIDE OF THE CUT INFUSION LINE. THE CATHETERS WERE BRIDGED WITH A 6-INCH PIECE OF HIGH-PRESSURE TUBING, A STOPCOCK AND A MALE-TO-MALE ADAPTER. THE BRIDGE WAS SECURED WITH SUTURE AND TAPE TO PREVENT DISCONNECTION. THROUGHOUT THIS REPAIR THE PT REMAINED IN HIS CRITICAL BUT STABLE CONDITION WITH NO NOTABLE CHANGE IN VITAL SIGNS OR PUMP FUNCTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TANDEM HEART PERCUTANEOUS VENTRICULAR ASSIST DEVICE NONE DSQ CARDIAC ASSIST, INC. NA NA

Patients

Seq Age Sex Outcome Treatment
1 37 YR Life Threatening