TIGRIS SYSTEM
Received May 5, 2017 · Event occurred Apr 7, 2017
Report 2024800-2017-00013 · MDR key 6549609
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Swelling
- Hypersensitivity/Allergic reaction
- Swelling
Narrative
Description of Event or Problem
ONE OF THE LABORATORY TECHNICIANS AT THE (B)(6) MEDICAL CENTER CLINICAL MICRO LAB, MS. (B)(6), DEVELOPED A HYPER-SENSITIVITY OVER 4 YEARS AGO TO BLEACH USED TO CLEAN THE TIGRIS INSTRUMENT. OVER TIME, THE IMPACT OF BLEACH HAS PROGRESSIVELY AFFECTED HER HEALTH, CAUSING MS. (B)(6) EYE LIDS TO SWELL SHUT. ON (B)(6) 2017, MS. (B)(6) WENT TO THEIR EMPLOYEE HEALTH CENTER FOR MEDICAL TREATMENT. SHE WAS EXAMINED BY A NURSE PRACTITIONER WHO RECOMMENDED HER TO AVOID BLEACH AND TO WEAR A POWERED AIR PURIFYING RESPIRATOR (PAPR). (B)(4) FSE VISITED THE CUSTOMER SITE AND VERIFIED THE LAB IS USING CORRECT VOLUMES TO MAKE THE FINAL CORRECT BLEACH DILUTIONS. BASED ON A REQUEST BY THE CUSTOMER, (B)(4) RECOMMENDED THE USE OF THE BLEACH ENHANCER INSTEAD OF BLEACH. (B)(4) FSE WENT OVER THE BLEACH ENHANCER PI WITH THE LAB SUPERVISOR (AMY CRIMSON) AND WORKED WITH OTHER STAFF TO DETERMINE THE VOLUMES NEEDED TO MAKE THE LEAST CONCENTRATED BLEACH PER PACKAGE INSERT INSTRUCTIONS. ONE CHANGE TO CUSTOMER'S PRACTICE IS TO MAKE AND DISCARD BLEACH WHEN THE MS. (B)(6) (EMPLOYEE WITH THE SENSITIVITY) HAS LEFT THE LAB FOR THE DAY.