WALKMED

Additional Manufacturer Narrative

ON 4/14/2017, MEDICAL SPECIALTIES DISTRIBUTORS (MSD), AN APPROVED SERVICE CENTER FOR WALKMED, RECEIVED A RETURN WM350VL PUMP DEVICE WITH A LABEL THAT THE DEVICE HAD BEEN EXPOSED TO A CHEMOTHERAPY SPILL. WALKMED BECAME AWARE OF THE INCIDENT DURING A REVIEW OF MSD'S SERVICE RECORDS FOR THE MONTH OF (B)(6) 2017, AT WHICH TIME, A COMPLAINT WAS INITIATED. WALKMED INITIATED SCAR 023 TO ADDRESS MSD'S DELAY IN COMMUNICATING THE EVENT TO WALKMED. ALTHOUGH THE PUMP ITSELF WAS RETURNED, THE COMPLAINT WAS RELATED TO THE RESERVOIR BAG, PER CONVERSATION WITH A NURSE AT THE USER FACILITY. THE RESERVOIR BAG WAS NOT RETURNED FOR EVALUATION AND NO INFORMATION REGARDING THE MAKE, MODEL, OR SERIAL NUMBER OF THE BAG COULD BE OBTAINED. RESERVOIR BAG NOT RETURNED

Description of Event or Problem

ACCORDING TO THE APRIL SERVICE REPORT FROM MEDICAL SPECIALTIES DISTRIBUTOR (MSD), MSD RECEIVED A PUMP UNIT WITH AN ORANGE NOTE STATING: CHEMOTHERAPY SPILL ON PUMP AND NOW KEEPS BEEPING OCCLUSION WHEN UNIT IS STARTED PER CONTACT WITH THE USER FACILITY, THE EVENT OCCURRED AT THE PATIENT'S HOME AND IT WOULD HAVE BEEN A BAG LEAK. THEY THINK THE PATIENT WASN'T EXPOSED BECAUSE THE BAG THEY KEEP THE PUMP AND EVERYTHING IN (DESCRIBED AS A FANNY PACK) MAY HAVE ACTED AS A BARRIER, BUT AREN'T CERTAIN. THEY ALSO ASSURED THAT WHILE THEY HAVE THE PUMP, THEY HAVEN'T BEEN USING IT.