inforMED
MalfunctionLHC

ORS-100N SOLUTION WARMER DRAPE

Received Jun 16, 2016

Report 8043817-2016-00034 · MDR key 5729293

Device

Generic name

Fluid Warming And Slush Drapes

Model number

ORS-100N

Lot number

SEE H10

Product problems

  • Break
  • Fluid/Blood Leak

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THIS EVENT WAS ASSOCIATED WITH ITEM NUMBER OM-ORS-100, LOT NUMBER 1052213 AND IS ASSOCIATED WITH THE POTENTIAL FOLLOWING ORS-100N NON STERILE MICROTEK LOT NUMBERS, D153021, D151621A, D152941, D151971, D151751, D151611, D151341, D153081A, D152761A, D153081, D153071, D153091, D153011, D153011A, AND D152891. NO DEVICE WAS RETURNED FOR EVALUATION. BASED ON THE DEVICE HISTORY RECORD REVIEW, THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. SINCE A SAMPLE WAS NOT PROVIDED, THE NON-CONFORMITY COULD NOT BE CONFIRMED.

Description of Event or Problem

SURGEON STATES THERE IS A LEAK IN SOME OF THE DRAPES. HE HAS FOUND A SMALL AMOUNT OF FLUID (LESS THAN 50CC) BETWEEN THE DRAPE AND FLUID WARMER IN TWO CASES. HE IS CONCERNED THERE IS A BREAK IN STERILITY.