INTRATEMP THERMABASIN DRAPE
Received Jun 5, 2018 · Event occurred May 10, 2018
Report 3013401749-2018-00004 · MDR key 7571298
Device
Generic name
Fluid Warming And Slush Drapes
Manufacturer
Microtek Medical, Inc.Model number
ITB100Lot number
UNKNOWN
Product problems
- Crack
- Crack
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ONE SAMPLE WAS RECEIVED 5/18/18 IN (B)(6). THE SAMPLE WAS OPENED, RED BAGGED AND CONTAMINATED. PHOTOS WERE TAKEN TO SHOW THE CRACK IN THE BOTTOM OF THE BASIN. THE SAMPLE IS BEING DISCARDED APPROPRIATELY AND WILL NOT BE SENT TO (B)(6). A SCAR WAS ISSUED TO THE SUPPLIER FOR THIS COMPLAINT. THE INVESTIGATION IS PENDING A RESPONSE FROM THE SUPPLIER.
Description of Event or Problem
END USER REPORTED BASIN HAS A CRACK IN IT. MEDWATCH FORM MW5077290 WAS RECEIVED ON 5/30/18 WITH THE FOLLOWING INFORMATION: ECOLAB INTRATEMP WARMING UNIT USED DURING SURGERY TO REPAIR AN ABDOMINAL AORTIC ANEURYSM. UPON TEAR DOWN OF STERILE FIELD, IT WAS NOTED THAT BASIN HAD A SMALL CRACK IN THE UNDERNEATH OF BASIN. CRACK WAS UNABLE TO BE VISUALIZED FROM STERILE PORTION. THE PHYSICIAN WAS NOTIFIED, INFECTIOUS DISEASE WAS CONSULTED, BASELINE BLOOD CULTURES WERE OBTAINED AND PATIENT WAS PLACED ON FURTHER ANTIBIOTIC THERAPY FOR 2 WEEKS. THE PATIENT WAS STABLE WITHOUT FEVER AND WAS CLOSELY MONITORED. BLOOD CULTURES HAD NO GROWTH AFTER 4 DAYS. PHARMACY WAS DOSING VANCOMYCIN.