CUSTOM ULTRASONICS
Report
- Report Number
- 2523209-2011-00002
- Event Type
- Other
- Date Received
- April 12, 2011
- Date of Event
- March 9, 2011
- Report Date
- April 8, 2011
- Manufacturer
- CUSTOM ULTRASONICS, INC.
- Product Code
- FLG
- PMA / PMN Number
- 983017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
SYSTEMS IN GI/ENDO: 83+9 SERIAL NUMBER (B)(4). SYSTEMS IN SPD: 83+2 SERIAL NUMBER (B)(4), 83+2 SERIAL NUMBER (B)(4).
CUSTOM ULTRASONICS RECEIVED A CALL ON (B)(6) 2011, FROM (B)(6) HOSPITAL. THAT PATIENTS WERE RANDOMLY EXPERIENCING FEVER AND CHILLS, LASTING 15 MINUTES AFTER VISITING THE HOSPITAL, TOTAL OF 14 PATIENTS. IT WAS EXPRESSED THAT THE FACILITY WERE USING STERILE WATER BEFORE ALL PROCEDURES BECAUSE THERE WAS ON 30 INCH WATER MAIN AROUND (B)(6) 2011 AND THE COUNTY HAD SWITCHED WATER SUPPLY FEED LINES TO THE HOSPITAL. AND INDICATED THEY WERE GOING TO HAVE THEIR WATER TESTED BY AN INDEPENDENT LAB, AND WOULD PROVIDE THE RESULTS. SERVICE DIRECTOR HAS SPOKEN WITH THE HOSPITAL TO VERIFY RESULTS, BUT WAS TOLD THEY STILL ARE NOT AVAILABLE. WE CAN NOT DETERMINE IF OUR SYSTEM 83 WAS THE CAUSE OF THIS EVENT, BUT SYSTEM 83 PLUS WAS BEING USED IN CONJUNCTION WITH AFOREMENTIONED EVENT AND IS CONSIDERED INTERNALLY AS A REPORTABLE EVENT. RECEIVED A CALL ON (B)(6) 2011, FROM INFECTION CONTROL DIRECTOR OF (B)(6) HOSPITAL STATING THAT AROUND (B)(6) 2011, THE HOSPITAL HAD VERY RANDOM PATIENT(S) WITH FEVER AND CHILL THAT LASTED FOR 15 MINUTES. THE FLEXIBLE SCOPES WERE (B)(6) 2011, FOR A CHECK OF THE SYSTEM, AND TO DETERMINE HOW THE STAFF WAS CONNECTING THEIR SCOPES, ALL FUNCTIONS OF THE SYSTEMS (2 83+9'S) WHERE OPERATING CORRECTLY AND THE STAFF WAS PRE-PROCESSING AND CONNECTING THE SCOPES (PENTAX) PROPERLY. THE FACILITY ONLY USES HOT WATER TO FEED THE SYSTEMS AND THE WATER TEMPERATURE IS 107 F. I ASKED WHO CHANGES THE WATER FILTERS AND DIRECTOR RESPONDED THE CLINICAL ENGINEERING STAFF. I ASKED IF THEY FOLLOWED THE PROTOCOL FOR WATER FILTERS CHANGES THE PERSON THAT CHANGES THE FILTERS WAS NOT IN SHE WOULD GET BACK TO ME ON THAT, ALONG WITH A TOTAL COUNT OF PROCEDURES AND THE NUMBER PATIENTS AFFECTED. FROM (B)(6) 2011 , I WAS TOLD 14 PATIENTS SHOWED SIGNS OF FEVER AND CHILLS, AND SYSTEM 2449-1 BAY 1 PROCESS COUNT WAS 7,463 AND BAY 2 WAS 10,015. SYSTEM 2449-2 BAY 1 PROCESS COUNT WAS 10,248 AND BAY 2 WAS 8,622. ALL PROCEDURES STARTED WITH STERILE WATER IN THE WATER BOTTLES AND IF THEY RAN OUT OF STERILE WATER THEY WOULD FILL THE BOTTLE WITH TAP WATER. DIRECTOR STATED THAT THEY HAD A 30 INCH WATER MAIN BREAK NOT LONG AGO ((B)(6) 2011) AND THE COUNTY HAD SWITCHED WATER SUPPLY FEED LINES THAT FEED THE HOSPITAL, SHE ALSO SAID THEY WERE HAVING THE WATER TESTED AND WILL SEND ME RESULTS (I HAVE NOT RECEIVED THEM AS OF (B)(6) 2011), SHE DID SAY THAT DIALYSIS (LOCATED A FLOOR BELOW THE GI/ENDO LAB) HAD A POSITIVE RESULT PRE AND POST FILTER FOR ENDOTOXINS IN THE WATER. DIRECTOR STATED THAT THEY HAVE AN INDEPENDENT WATER TESTING COMPANY COMING IN SO I MADE ARRANGEMENTS CU SERVICE TECHNICIAN AND MYSELF TO BE THERE AND ASSIST THEM ON (B)(6) 2011. WHEN WE ARRIVED A PLUMBER WAS INSTALLING EYE WASH STATION IN THE DEPARTMENT AND IN THE SCOPE REPROCESSING ROOM AND THEY WHERE TURNING THE WATER LINES ON AND OFF DURING THE DAY. WE HELPED THE TESTING LAB TAKE WATER SAMPLES FROM PRE-FILTER, POST FILTER, AND FROM ALL BAYS FROM THE WATER INLET (LOCATED IN WASH CHAMBER) AND THE SPRAY HOSES. WE MEET WITH THE HOSPITAL INFECTION CONTROL DEPARTMENT, AND CLINICAL ENGINEERING - THE PERSON RESPONSIBLE FOR CHANGING THE FILTERS, PLUMBERS, FACILITIES DIRECTOR. THE CLINICAL ENGINEER STATED THAT HE ONLY CHANGED THE FILTERS AND NEVER CLEANED OR DECONTAMINATED THE FILTER HOUSINGS AND SYSTEMS WATER INLET LINES, DETERGENT LINES OR ALCOHOL LINES. FOLLOWING SAMPLING AND THE MEETINGS ON (B)(6) 2011, WE INSTALLED 2 NEW SETS OF WATER FILTERS HOUSINGS PART NUMBER 13049 WHICH IS A 25/5/.01 MICRON FILTER ASSEMBLY, PERFORMED A PREVENTIVE MAINTENANCE ON BOTH SYSTEMS REPLACED THE SOLENOID KITS, SPRAY HOSES AND FOLLOWED THE BLEACHING PROCESS OUTLINED IN THE SYSTEMS MANUAL. THE GI/ENDO DEPARTMENT IS NOT USING THE SYSTEM 83+9'S AT THIS POINT, ALTHOUGH THEY DO NOT KNOW IF THE SYSTEMS ARE INVOLVED. DIRECTOR SAID SHE WOULD NOTIFY ME OF THE RESULTS. DURING THE MEETING IT WAS BROUGHT TO OUR ATTENTION THAT RPZ VALVES WERE INSTALLED ON THE WATER FEED LINES TO THE REPROCESSING ROOM AND ON INSPECTION WE) NOTICED IT WAS LEAKING AT THE DIAPHRAGM AND HAD NOT BEEN SERVICED FOR SOME TIME, HANGING ON THE RPZ VALVE WAS A PLASTIC BAG WITH REPLACEMENT PARTS FOR THAT VALVE. THE HOSPITAL MOVED ALL GI SCOPE RE-PROCESSING TO THE SPD DEPARTMENT, THERE ARE 2 83+2'S IN SPD. WE CHECKED THE TWO SYSTEMS WHICH WHERE FUNCTION TO SPEC. THE FILTERS WHERE DIRTY AND WHEN WE ASKED IF THE SAME PERSON WHO CHANGES THE FILTERS IN WAS RESPONSIBLE FOR THE FILTERS IN SPD WE WERE INFORMED THAT A DIFFERENT PERSON TOOK CARE OF THEM. HE WAS NOT IN TO ASK HIM HIS PROCEDURE FOR CHANGING THE FILTERS. THE FILTERS WERE DIRTY FROM FILTERING THE WATER, WHICH IS DRAWN FROM A LAKE. DIRECTOR STATED THEY WOULD LIKE TO SCHEDULE AN IN-SERVICE ON THE SYSTEM FOR HIS STAFF. I RECOMMENDED THAT THEY ORDER NEW WATER FILTER HOUSINGS, A WATER SOFTENER (ALSO ONE FOR GI) BECAUSE THE FACILITIES USE OPA AND CHANGE THE FILTERS PER MANUAL INSTRUCTIONS. I HAVE CALLED HIM ON (B)(6) 2011, TO ARRANGE THE IN-SERVICE BUT HE HAS NOT RETURNED MY CALL. I ALSO CALLED INFECTION DIRECTOR ON (B)(6) 2011, TO SEE IF THE RESULTS CAME BACK AND WAS TOLD NOT YET. I WILL CALL HER ON (B)(6) 2011 AGAIN FOR ANY MORE INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CUSTOM ULTRASONICS | SYSTEM 83 PLUS | FLG | CUSTOM ULTRASONICS, INC. | SYSTEM 83+9 | EQ 2449-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |