EASYPUMP

Description of Event or Problem

AS REPORTED ON MW5096817: PATIENT SCHEDULED ON (B)(6) 2020 FOR FOLFOX CHEMOTHERAPY. THE 46-HOUR TAKE HOME FLUOROURACIL DOSE WAS COMPOUNDED IN A B BRAUN EASYPUMP ELASTOMERIC DEVICE (270-54-S). THE CORRECT DRUG, THE CORRECT DRUG AND BASE SOLUTION VOLUME AND CORRECT SIZE/RATE ELASTOMERIC DEVICE WAS USED TO PREPARE THE 5FU DOSE FOR THIS PATIENT AS CONFIRMED IN THE COMPOUNDING CAMERA IMAGES. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 WITH RECTAL BLEEDING. LAB TESTS RESULTED PLT OF 9. AT 4PM ON (B)(6) 2020, IT WAS ALSO NOTED IN THE HOSPITALIZATION RECORD THAT THE ELASTOMERIC DEVICE WAS EMPTY. THE ELASTOMERIC DEVICE CONTAINING CHEMOTHERAPY SET TO INFUSE OVER 46 HOURS WAS ATTACHED ON (B)(6) 2020 AT 1148AM. THE DEVICE HAS AN ACCURACY OF INFUSION DURATION +/- 15% AND SHOULD HAVE ENDED BETWEEN 448AM AND 348PM ON (B)(6) 2020. THE ELASTOMERIC RAN TO FAST AND EMPTIED 11 HOURS EARLY. FDA SAFETY REPORT ID # (B)(4). AS PART OF AN INTERNAL NONCONFORMANCE, THIS IMPORTER MDR IS BEING SUBMITTED RETROACTIVELY. PLEASE NOTE THAT THE ASSOCIATED MANUFACTURER MDR FOR THIS EVENT, 9610825-2020-00261, HAD ALREADY BEEN PREVIOUSLY SUBMITTED TIMELY ON 23OCT2020. AS B. BRAUN MEDICAL, INC. SUBMITTED THE MANUFACTURER MDR ON BEHALF OF THE MANUFACTURER, THE IMPORTER MDR WAS INADVERTENTLY MISSED.