EASYPUMP

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION: "AN ONCOLOGY DAY CLINIC REPORTED AN INCREASED NUMBER OF INSTANCES WHERE THE PUMPS APPEARED TO HAVE SHORTER RUN TIMES. NORMALLY, THE PUMPS WERE INTENDED TO RUN FOR 48 HOURS (WITH A FILL VOLUME OF 100 ML IN EACH CASE); HOWEVER, ACCORDING TO REPORTS FROM PATIENTS AND THE ONCOLOGY DAY CLINIC, THEY HAD FINISHED INFUSING AFTER APPROXIMATELY 24 HOURS. IN SOME PATIENTS, THIS RESULTED IN SIDE EFFECTS SUCH AS A DROP IN BLOOD PRESSURE."

Additional Manufacturer Narrative

THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW- UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4) PREMARKET SUBMISSION # K081905.