FDA Adverse Event Malfunction Summary report: N

COLOR CUFF

MDR report key: 16536551 · Received March 14, 2023

Report

Report Number
16536551
Event Type
Malfunction
Date Received
March 14, 2023
Date of Event
February 20, 2023
Report Date
February 24, 2023
Manufacturer
STRYKER CORPORATION
Product Code
KCY
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

NEW STRYKER COLOUR CUFF STERILE DISPOSABLE TOURNIQUET SYSTEM FOR OPERATING ROOM HAS BEEN VERY POOR QUALITY AND CONSTANTLY LEAKS AT THE INSERTION PORTS LEADING TO THE TOURNIQUET INFLATION GENERATOR. THIS PARTICULAR CASE THE TOURNIQUET (34CIRC INCH SINGLE PORT PURPLE TOURNIQUET) WAS LEAKING AT BOTH THE INSERTION PORT AND THE CUFF ITSELF. THE CIRCULATING NURSE HAD TO CLIMB UNDER THE STERILE FIELD WITH AN OPEN SURGICAL INCISION JUST BELOW THE TOURNIQUET, REMOVE DEFECTIVE TOURNIQUET AND APPLY NEW NON-DEFECTIVE TOURNIQUET. THIS GAVE POTENTIAL FOR THE STERILE FIELD TO BE BREACHED AND CONTAMINATED. THIS COULD HAVE CAUSED SURGICAL SITE INFECTION AND A NEGATIVE OUTCOME FOR THE PATIENT. FOLLOWING THE APPLICATION OF A NEW TOURNIQUET, THE SURGEON CHANGED HIS GLOVES, A NEW DRAPE WAS PLACED AROUND THE AREA AND THE SURGICAL SITE WAS RE-PREPPED BY SURGEON AROUND THE OPEN INCISION. SURGERY PROCEEDED BUT THIS ALSO DELAYED THE SURGERY PROGRESSION BY APPROXIMATELY 20 MINUTES. ALSO INCREASING RISK OF INJURY, INFECTION AND OTHER NEGATIVE OUTCOMES. STRYKER TOURNIQUET ISSUES ARE A KNOW PROBLEM AT THIS TIME. WE ARE WORKING ON GETTING REPLACEMENT TOURNIQUETS FROM AN ALTERNATE VENDOR. TYPICALLY, THE DEFECT IS NOTED PRIOR TO INCISION SO APPROPRIATE MODIFICATIONS CAN BE MADE. THE ISSUES ARE WITH THE TOURNIQUET CUFF, NOT THE TOURNIQUET BOX THAT INFLATES THE CUFF. STRYKER WENT ON BACK ORDER WITH THEIR CUFFS A FEW MONTHS AGO. THEY FOUND ANOTHER MANUFACTURER, BUT THE NEW CUFFS WE RECEIVED LEAKED. THIS HAS BEEN AN ISSUE FOR A COUPLE OF MONTHS, BUT DUE TO BACK ORDERS IT IS DIFFICULT TO GET ANY TOURNIQUET CUFFS. SOME OF THE STRYKER CUFFS ARE OK, SOME STILL LEAK. THE CUFF IS USUALLY CHECKED TO MAKE SURE IT IS HOLDING IT'S PRESSURE BEFORE THE PATIENT IS DRAPED AND THE INCISION IS MADE. THIS ONE FAILED AFTER ALL OF THAT. IT HASN'T BEEN ISOLATED TO ONE LOT NUMBER HOWEVER, IT HAS BEEN AN ISSUE WITH MANY STRYKER CUFFS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
711796 COLOR CUFF TOURNIQUET, PNEUMATIC KCY STRYKER CORPORATION 5921-034-135 0000183125

Patients

Seq Age Sex Outcome Treatment
1 23725 DA Male