Description of Event or Problem · 1
DURING CALLBACKS THE DAY AFTER SURGERY, I DISCUSSED THE PATIENT'S POLAR CARE. HE STATED HE DIDN'T THINK THE DEVICE WAS WORKING. I TOLD HIM HE COULD COME IN AND I COULD SEE IF I COULD DETERMINE WHAT THE PROBLEM WAS. THE PATIENT CAME IN TO POST-OP. HE STATED HE HAD TROUBLE-SHOOTED THE POLAR CARE BOX WITH THE COMPANY'S CUSTOMER SERVICE AND THEY STATED THAT HE NEEDED A NEW BOX. WHEN HE ARRIVED IN POST-OP I PLUGGED THE MACHINE INTO THE POLAR CARE SLEEVE ON THE WRIST. IT WAS NOT GETTING COLD. THE DOCTOR WAS NOTIFIED; HE SAID I COULD UNDO THE BANDAGE AND PLACE A NEW SLEEVE ON THE PATIENT. A NEW SLEEVE WAS TRIED OUT WITH THE NEW POLAR CARE BOX PRIOR TO ITS PLACEMENT ON THE PATIENT, IT GOT COLD ALL OVER. I PLACED THE NEW SLEEVE ON THE PATIENT'S WRIST AND THEN ATTACHED THE NEW POLAR CARE BOX. THE PATIENT STATED IT GOT COLD "IMMEDIATELY". THE PATIENT WAS HAPPY WHEN HE LEFT. THE BAD WRIST SLEEVE AND BOX WERE GIVEN TO THE OR MANAGER.======================MANUFACTURER RESPONSE FOR POLAR CARE WRIST SLEEVE/POLAR CARE PUMP, POLAR CARE KODIAK (PER SITE REPORTER).======================THEY SAID THAT IT WAS THE PUMP THAT WAS THE PROBLEM, BUT OUR FACILITY DETERMINED THAT WHILE THAT MAY BE THE CASE THE SLEEVE ALSO SEEMED TO BE BLOCKED. THE MANUFACTURER SUGGESTED GETTING A NEW PUMP WHICH WAS DONE BUT SLEEVE STILL DID NOT GET COLD, AND A NEW PUMP AND NEW SLEEVE WERE OBTAINED AND WORKED. THE PUMP AND SLEEVE THAT DID NOT WORK WERE BROUGHT TO OUR OFFICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ICE/COLD THERAPY FOLLOWING SURGERY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.