MEMBRANE CHANGER (RELOADABLE) / SINGLE UNIT

Description of Event or Problem

SENTEC AG INITIATED A CUSTOMER INFORMATION LETTER FOR MEMBRANE CHANGER PRODUCTS DUE TO SPECIFIC LOTS POSSIBLY CONTAINING A NON-CONFORMING DEFECT. DURING THE MANUFACTURING PROCESS THERE WERE COMPONENTS THAT REQUIRED REWORK AND DURING THAT STEP, BUT BEFORE ASSEMBLY, AN ADDITIONAL PIECE OF MATERIAL MAY HAVE BEEN LEFT IN THE DEVICE. PLEASE NOTE WE NEVER ACTUALLY RECEIVED THIS NOTICE FROM SENTEC AG. WE DISCOVERED THE CUSTOMER INFORMATION LETTER THROUGH ECRI. THE POTENTIAL FOR HARM IS BASED ON THE LETTER FROM SENTEC AG STATING THE DEFECT COULD HAVE AN IMPACT ON MEASUREMENT READINGS, IMPACT ON THE SENSOR MEMBRANE AND POTENTIAL HARM TO PATIENT SKIN. BASED ON THIS INFORMATION, WE REQUESTED REPLACEMENT PRODUCTS FROM SENTEC AG. SENTEC AG DECLINED REPLACEMENT AND TOLD US THE DEFECT POSED NO IMPACT ON SKIN INTEGRITY. THIS RESPONSE DIFFERS FROM THE ALERT LETTER STATING IT AS A POTENTIAL FOR HARM.