ORS-320 SLUSH WARMER DISC DRAPE

Additional Manufacturer Narrative

THE SAMPLE WAS RECEIVED FOR EVALUATION. THE CUSTOMER HAD MARKED WHAT THEY DESCRIBED AS A BREAK ON THE SLUSH SIDE OF THE UNIT NEAR THE DISK. THE DRAPE WAS TESTED WITH WATER ON BOTH SIDES OF THE UNIT, SLUSH AND WARMER SIDE, AND NO LEAKS WERE FOUND. THE DHR WAS REVIEWED FOR THIS LOT AND IT WAS OBSERVED THAT (B)(4) CASES WERE MANUFACTURED FROM 03/28/2017 TO 03/31/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DEVICE HISTORY RECORD AND THE SAMPLE REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. IT IS NORMAL FOR A SMALL AMOUNT OF LIQUID TO COLLECT IN THE BASIN DUE TO CONDENSATION. AFTER USE, DRY THE BASIN WITH A LINT-FREE CLOTH AND ISOPROPYL ALCOHOL. REFER TO OPERATIONS MANUAL FOR THE ORS-1075HS AND ORS-1058HS HUSH SLUSH SURGICAL SLUSH SYSTEMS. SINCE IT IS NORMAL FOR LIQUID TO BE IN THE SLUSH BASIN DUE TO CONDENSATION AND THE NON CONFORMITY WAS NOT FOUND DURING THE SAMPLE REVIEW, NO FURTHER ACTIONS WILL BE TAKEN.

Description of Event or Problem

SALES REP RECEIVED AN EMAIL FROM THE HOSPITAL ON (B)(6) 2018 STATING THAT DURING A RECENT CT SURGICAL CASE, WATER WAS FOUND UNDERNEATH THE ORS-320 DRAPE. CUSTOMER STATED THAT NOTHING WAS INTRODUCED INTO THE BASIN THAT WOULD CAUSE A HOLE OR A TEAR. HOSPITAL PERSONNEL LOCATED THE BREACH AND MARKED IT ON THE DRAPE, ALONG WITH TYING A SUTURE AROUND IT. DURING A CE PRESENTATION AT THE HOSPITAL ON (B)(6) 2018, THE OPERATING ROOM RESOURCE NURSE ASKED THE REP IF THEY HAD THE DRAPE. REP REPLIED HE HAD PICKED IT UP. HE WAS THEN TOLD THAT THEY DO PUT ITEMS INTO THE BASIN THAT THEY SHOULDN'T. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.