Description of Event or Problem · 1
ON 05/23/2000, THE PHYSICIAN CONTACTED THE MANUFACTURER'S PRODUCT MANAGER AND ASKED ABOUT THE PRIMING VOLUMES PRINTED ON THE EXTENSIONS AND THE PRIMING VOLUME STICKER PROVIDED WITH THE PRODUCT. THE PHYSICIAN FIRST CLAIMED THAT THE PRIMING VOLUMES WERE INCORRECT BECAUSE THE ARTERIAL SIDE OF THE CATHETER COULD NOT BE LARGER THAN THE VENOUS SIDE. THE MFR'S PRODUCT MANAGER INFORMED THE PHYSICIAN THAT THE CATHETER WAS INDEED LARGER ON THE ARTERIAL SIDE. THE PHYSICIAN RAN A DESK TEST SHOWING THAT AT THE PRINTED PRIMING VOLUME, THE PHYSICIAN HAD FLUID COMING OUT THE END OF THE CATHETER. THE MFR'S PRODUCT MANAGER SPOKE WITH THE MFR'S ENGINEERING DEPARTMENT AND WAS TOLD THAT THE PRIMING VOLUME IS MEASURED AND THEN 10% IS ADDED TO THAT VOLUME TO ENSURE IT IS PRIMED TO THE END OF THE CATHETER. THE PHYSICIAN THEN STATED THAT THE PROTOCOL FOR THE HOSPITAL WAS TO USE 10,000 UNITS OF HEPARIN PER CC OF SALINE AS A STANDARD FLUSH. THE MFR RECOMMENDS 1000IU/ML TO 5000IU/ML AT THE APPROPRIATE VOLUME (PRINTED ON THE EXTENSION). ON 6/24/2000, THE MFR'S SALES REPRESENTATIVE WAS INFORMED BY THE FACILITY'S CHIEF TECHNICIAN OF THE FOLLOWING: THE DIALYSIS NURSE FLUSHED THE CATHETER BASED ON THE PRIMING VOLUME PRINTED ON THE CATHETER IN THE PT. THIS WAS 5 OR 6 DROPS TOO MUCH WHICH RESULTED IN OVERDOSING THE PT WITH HEPARIN CAUSING THEM TO HEMORRHAGE. THE PHYSICIAN OPENED A SECOND KIT AND AGAIN FOUND INCORRECT PRIMING VOLUMES ON THE ORANGE STICKER IN THE KIT. THE PHYSICIAN ACTUALLY FILLED THE SECOND CATHETER TO CHECK VOLUME, SO THE PHYSICIAN IS ADAMANT THAT THEY ARE MISLABELED RESULTING IN OVERDOSE OF HEPARIN. THE CATHETER IN QUESTION REMAINS IMPLANTED. AN UNUSED DEVICE (DIFFERENT CATALOG/LOT NUMBER) IS SCHEDULED TO BE RETURNED TO THE MFR FOR EVALUATION. NO FURTHER DETAILS WERE PROVIDED.