BREG
Received Aug 9, 2017 · Event occurred May 1, 2017
Report 6776818 · MDR key 6776818
Device
Generic name
Pack, Hot Or Cold, Water Circulating
Manufacturer
Breg, Inc.Model number
POLAR CARE CUBECatalog number
10701
Lot number
272130207
Product problems
- Leak/Splash
Patient
51 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PATIENT COLD THERAPIES POST-ORTHO SURGERY; USING COLD PACKS WHICH LEAKED. NO PATIENT HARM.
Description of Event or Problem
PATIENT COLD THERAPIES POST-ORTHO SURGERY; USING COLD PACKS WHICH LEAKED. PATIENT A. HAD KNEE SURGERY ON 4 MONTHS AGO. THEY WERE DISCHARGED AND A WEEK LATER HER KNEE PAD WAS NOT GETTING COLD. THE PATIENT'S CAREGIVER FELT THE DEVICE AND IT WAS VERY HOT. THEY UNPLUGGED IT AND CALLED THE HOSPITAL. PATIENT B. PATIENT STATES THAT AFTER THEY WERE DISCHARGED HOME, THE POLAR CARE BEGAN LEAKING OUT OF THE MAIN UNIT. THEY BROUGHT THE UNIT BACK TO ORTHOPEDICS AND IT WAS EXCHANGED FOR A NEW ONE. PATIENT C. PATIENT BROUGHT POLAR CARE BACK TO THE HOSPITAL AFTER DISCHARGE AS PARTS HAD BROKEN AND WANTED A REPLACEMENT. PATIENT WAS GIVEN A NEW POLAR CARE AND OLD ONE STORED FOR RISK MANAGEMENT. PATIENT D. POLAR CARE PAD FOR KNEE WAS LEAKING. RN REPLACED IT WITH ANOTHER ONE AND THAT WORKED FINE. DEFECTIVE PAD WAS TAKEN TO CARE COORDINATOR TO EXCHANGE. PATIENT E. POLAR CARE CUBE IS LEAKING AT THE END OF THE HOSE WHERE IT ATTACHES TO THE PAD THAT GOES ON THE PATIENT'S KNEE. IT WAS REPLACED WITH A NEW ONE AND THE DEFECTIVE ONE SENT TO RISK MANAGEMENT.