Description of Event or Problem · 0
KORU MEDICAL BECAME AWARE OF MW5112678 RECEIVED THROUGH THE FDA MEDWATCH PROGRAM STATING "INDICATION: OTHER NEUTROPENIA, SYSTEMIC INVOLVEMENT OF CONNECTIVE TISSUE, UNSPECIFIED, NONFAMILIAL HYPOGAMMAGLOBULINEMIA. PT STATED PUMP MALFUNCTIONED AT THE START OF INFUSION IT DOESN'T SLOW DOWN JUST PUSHES MEDICINE ALL THE WAY THROUGH UNTIL THE POINT IT POPS OUT AND IT PULLS AT NEEDLE IN STOMACH. UNKNOWN WHEN PT STOPPED USING THIS PUMP. NO FURTHER INFORMATION PROVIDED. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? YES; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NEEDLES TUGGED AT SKIN UNK. IF YES, WAS ANY MEDICAL INTERVENTION PROVIDED? NEW FREEDOM 60 PUMP WAS SENT TO PT; IS THE ACTUAL DEVICE AVAILABLE FOR INVESTIGATION? YES; IT WAS RETURNED TO CVS SPECIALTY IN PUMP RETURN BOX. DID WE REPLACE THE DEVICE? YES; DID THE PT HAVE A BACKUP DEVICE THEY WERE ABLE TO SWITCH TO? NO; REPORTED TO (B)(6) BY PT/CAREGIVER." A GOOD FAITH EFFORT WAS SENT TO THE INITIAL REPORTER ON 27-OCT-2022. A RESPONSE WAS RECEIVED STATING THE PATIENT DID NOT PROVIDE THE PUMP SERIAL NUMBER OR EXPIRATION DATE INFO. HOWEVER, UPON FURTHER INVESTIGATION THERE IS A REASONABLE POSSIBILITY THE PUMP IN QUESTION MAY BE SERIAL S015086661, DISPENSE DATE: 04/21/2022, RETURN DATE: STILL WITH PATIENT. IN ADDITION, CVS PERSONNEL CLARIFIED DETAILS ON MW5112678 REGARDING THE PUMP RETURN AND STATED "AT THE TIME OF THIS REPORT, CVS WAS JUST SENDING A RETURN PUMP BOX TO THE PT (ALONG WITH A NEW PUMP), THEY HADN'T ACTUALLY RETURNED THE DEFECTIVE PUMP TO US YET. THE REPORT (MW5112678) SHOULD HAVE BEEN WORDED: IT WILL BE RETURNED TO CVS SPECIALTY IN PUMP RETURN BOX, NOT IT WAS RETURNED TO CVS SPECIALTY IN PUMP RETURN BOX". CVS PERSONNEL ALSO STATED THEY WOULD CONFIRM WITH THE PATIENT IF THE PUMP HAS BEEN RETURNED, AND IF NOT, WOULD REQUEST THE PUMP TO BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER ON 31-OCT-2022 STATING CVS PERSONNEL SPOKE WITH THE PATIENT WHO STATED THAT THEY HAD INCORRECT TUBING, BUT THEY NOW HAVE THE CORRECT SUPPLY AND THE ISSUE HAS BEEN RESOLVED. THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RECEIVED BY KORU FOR EVALUATION AT THIS TIME.KORU MEDICAL IS CURRENTLY INVESTIGATING THIS EVENT.THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.