Description of Event or Problem · 0
SHE PLACED IT [CLEO] PERI UMBILICALLY BUT COMPLAINED OF PAIN; BRAND ISSUE; HAVING SITE PAIN FROM CLEO TUBING [INFUSION SITE PAIN] SUBCUTANEOUS SITE ISSUES [INFUSION SITE REACTION]. HAD BEEN PLACING HER CLEO SITE IN HER FLANK AREA AND WHEN SHE SLEEPS ON IT, IT [CLEO] BECOMES DISLODGED [DEVICE USE ERROR]. HAD BEEN PLACING HER CLEO SITE IN HER FLANK AREA AND WHEN SHE SLEEPS ON IT, IT [CLEO] BECOMES DISLODGED [DEVICE DISLODGEMENT]. [CLEO] PLACEMENT ISSUE [DEVICE PLACEMENT ISSUE] YEAR OLD, FEMALE PATIENT BEGAN THERAPY WITH REMODULIN (TREPROSTINIL SODIUM, CONCENTRATION 2.5 MG/ML) DELIVERED VIA REMUNITY [SELF-FILLED] PUMP ON AN UNREPORTED DATE IN (B)(6) 2023 FOR PULMONARY ARTERIAL HYPERTENSION (PAH). THE CURRENT DOSE WAS REPORTED AS 0.01644 G/KG, CONTINUOUS VIA SUBCUTANEOUS (SQ) ROUTE. IT WAS REPORTED THAT SHE HAD BEEN PLACING HER CLEO SITE IN HER FLANK AREA AND WHEN SHE SLEEPS ON IT [MOSTLY ALWAYS], IT BECOMES DISLODGED (DEVICE USE ERROR AND DEVICE DISLOCATION). PREVIOUSLY SHE PLACED IT PERI UMBILICALLY BUT COMPLAINED OF PAIN AND IT WAS NOT ASSESSED HOW CLOSE TO HER UMBILICUS SHE WAS PLACING THE CLEO. FURTHER, IT WAS REPORTED THAT HER SUBCUTANEOUS SITE ISSUES (INFUSION SITE REACTION) WORSENED WHEN SHE WAS TRANSITIONED OFF THE QUICKSET (B)(6) CATHETER ONTO THE CLEO SETS. HER PROBLEM DID NOT SEEM TO BE SPECIFICALLY A TUBING ISSUE AS MUCH AS A PLACEMENT ISSUE (DEVICE PLACEMENT ISSUE) AND A BRAND ISSUE AS THE PATIENT WAS HAVING SITE PAIN FROM CLEO TUBING (INFUSION SITE PAIN). CO-SUSPECT PRODUCT INCLUDED CLEO INFUSION SET AND QUICKSET (B)(6) CATHETER. CONCOMITANT MEDICATION INCLUDED: ADCIRCA (TADALAFIL). RELEVANT MEDICAL HISTORY INCLUDED: PAH (PULMONARY ARTERIAL HYPERTENSION). ACTION TAKEN WITH SUBCUTANEOUS REMODULIN DOSE WAS NOT CHANGED DUE TO THE EVENTS OF INFUSION SITE PAIN AND INFUSION SITE REACTION. AT THE TIME OF REPORTING, THE OUTCOME OF INFUSION SITE PAIN WAS UNKNOWN WHEREAS THE OUTCOME OF INFUSION SITE REACTION WAS CONSIDERED AS NOT RESOLVED. THE REPORTER DID NOT PROVIDE CAUSALITY FOR THE EVENTS OF INFUSION SITE PAIN AND INFUSION SITE REACTION WITH SQ REMODULIN. THE REPORTER'S CAUSALITY FOR THE EVENTS OF INFUSION SITE PAIN AND INFUSION SITE REACTION WITH CLEO INFUSION SET WAS CONSIDERED TO BE POSSIBLY RELATED. THE REPORTER'S CAUSALITY FOR THE EVENT OF INFUSION SITE REACTION WITH QUICKSET (B)(6) CATHETER WAS CONSIDERED TO BE POSSIBLY RELATED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).