inforMED
MalfunctionIME

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 CUBE

Catalog 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.