CUSTOM ULTRASONICS

Report

Report Number: 2523209-2011-00007
Event Type: Other
Date Received: August 27, 2012
Date of Event: March 9, 2011
Report Date: August 27, 2012
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

Additional Manufacturer Narrative · 1

(B)(6) HOSP RECEIVED A CALL ON (B)(6) 2011 FROM (B)(6) INFECTION CONTROL DIRECTION OF (B)(6)HOSPITAL STATING THAT AROUND (B)(6) 2011, THE HOSPITAL HAD VERY RANDOM PT(S) WITH FEVER AND CHILL THAT LASTED FOR 15 MINUTES. THE FLEXIBLE SCOPES WERE DIFFERENT MODELS, UPPER AND LOWER GI SCOPES, I TRAVELED TO THE HOSPITAL ON (B)(4) 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 FILES AND (B)(6) SAID 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 PTS AFFECTED. AS OF (B)(6) 2011, FROM (B)(6) 2011 WAS TOLD THAT PTS THAT SHOWED SIGNS OF FEVER AND CHILLS TOTALED 14. THE 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. (B)(6) STATED THAT THEY HAD A 30 INCH WATER MAIN BREAK NOT LONG AGO 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 YET RECEIVED THEM AS OF (B)(4) 2011), SHE DID SAY THAT DIALYSES (LOCATED A FLOOR BELOW THE GI/ENDO LAB) HAD A POSITIVE RESULT PRE AND POST FILTER FOR ENDOTOXINS IN THE WATER. (B)(6) HAD STATED THAT THEY HAVE AN INDEPENDENT WATER TESTING COMPANY COMING IN SO I MADE ARRANGEMENT FOR (B)(6) 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 MET THE HOSPITAL INFECTION CONTROL DEPARTMENT WHICH INCLUDED DR. (B)(6), (B)(6), (B)(6) THE PERSON RESPONSIBLE FOR CHANGING THE FILTERS, PLUMBERS, (B)(6), AND (B)(6). THE (B)(6) 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. (B)(6) SAID SHE WOULD NOTIFY ME OF THE RESULTS. DURING THE MEETING IF WAS BROUGHT TO OUR ATTENTION THAT RPZ VALVES WERE INSTALLED ON THE WATER FEED LINES TO THE SCOPE REPROCESSING ROOM AND ON INSPECTION WE (DR (B)(6) AND MYSELF) 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 T 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 GI WAS RESPONSIBLE FOR THE FILTERS IN SPD WE WHERE 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. (B)(6) 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)(4) 2011 TO ARRANGE THE IN-SERVICE BUT HE HAS NOT RETURNED MY CALL. I ALSO CALLED (B)(6) ON (B)(4) 2011 TO SEE IF THE RESULTS CAME BACK AND WAS TOLD NOT YET. I WILL CALL (B)(6) ON (B)(4) 2011 AGAIN FOR ANY MORE INFO. SYSTEMS IN GI/ENDO: 83+9 SERIAL NUMBER (B)(4) ; 83+9 SERIAL NUMBER (B)(4). SYSTEMS IN SPD: 83+2 SERIAL NUMBER (B)(4); 83+2 SERIAL NUMBER (B)(6).

Description of Event or Problem · 1

THIS REPORT WAS COMPLETED PER THE REQUEST OF THE FDA MEDWATCH TEAM. THE ORIGINAL REPORT 2523209-2011-00002 DOCUMENTED 2 EQUIPMENT SERIAL NUMBERS. PER THE MEDWATCH TEAM, EACH REPORT SERIAL NUMBER OF A MACHINE AFFECTED, SHOULD HAVE ITS OWN FORM 3500A. CUSTOM ULTRASONICS RECEIVED A CALL ON (B)(6) 2011 FROM (B)(6) HOSPITAL. THAT PTS WERE RANDOMLY EXPERIENCING FEVER AND CHILLS. LASTING 15 MINUTES AFTER VISITING THE HOSPITAL, A TOTAL OF 14 PTS. IT WAS EXPRESSED THAT THE FACILITY WERE USING STERILE WATER BEFORE ALL PROCEDURES BECAUSE THERE WAS A 30" WATER MAIN BREAK ON OR ABOUT (B)(6) 2010 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. (B)(4) HAS SPOKEN WITH THE HOSPITAL TO VERIFY RESULTS BUT WAS TOLD THEY WERE STILL NOT AVAILABLE (AS OF 2011). WE CANNOT 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CUSTOM ULTRASONICS	SYSTEM 3 PLUS	FLG	CUSTOM ULTRASONICS INC.	SYSTEM 83+9	EQ-2249-2

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other