6 FOOT DISPOSABLE EXTENSION CABLES WITH SAFE CONNECT/SCREW-DOWN

Description of Event or Problem

PATIENT WITH TEMPORARY PACING VIA EPICARDIAL WIRES EXPERIENCED ASYSTOLE REQUIRING CPR AND EPINEPHRINE TO BE PROVIDED. ROSC [RETURN OF SPONTANEOUS CIRCULATION] WAS OBTAINED AND PACER WAS ON AND SET FOR BACK UP, IT WAS CONFIRMED TO BE OPERATIONAL (CAPTURING AND SENSING) EARLIER IN THE DAY. POST CODE IT APPEARED THE PINS CONNECTED TO THE PACING BOX WERE LOOSE. THE LOOSE CONNECTIONS ARE OCCURRING REGULARLY NOW, WITH LATEST EVENT [REDACTED]. THIS IS OCCURRING WITH STAFF THAT ARE VERY SEASONED AS WELL AS NEWER STAFF. CONNECTIONS ARE BEING CHECKED ACCORDING TO PRACTICE GUIDELINES. THE NURSE EDUCATOR WHO HAS BEEN IN THE UNIT SINCE PRIOR TO THE CONVERSION TO THESE DISPOSABLE CONNECTORS APPROXIMATELY 15 YEARS AGO SAID THERE HAS BEEN A MARKED INCREASE IN DISCONNECTIONS FROM THE PATIENT WIRES, AS THOUGH THE BARRELS ARE STARTING TO FAIL TO GRASP THE PATIENT WIRES AS SUCCESSFULLY. THE DISCONNECTIONS ARE HAPPENING INSIDE THE BARREL OF THE RED AND BLACK CONNECTORS.

Additional Manufacturer Narrative

THIS MEDSUN REPORT WAS RECEIVED ON 02 MAR 2026 FROM THE FDA. THIS WAS NOT REPORTED TO REMINGTON MEDICAL BY YALE-NEW HAVEN HOSPITAL. THE SUSPECT DEVICE WAS NOT RETURN TO REMINGTON MEDICAL TO CONFIRM A MALFUNCTION OR TO DO A PROPER EVALUATION AND INVESTIGATION. NO LOT NUMBER WAS PROVIDED. NO OTHER COMPLAINT HAS BEEN RECEIVED FOR THE PRODUCT CODE LISTED ABOVE (FL-601-97-B).