3ME-SC203A TSCDII 110V
Report
- Report Number
- 1722028-2018-00357
- Event Type
- Malfunction
- Date Received
- December 21, 2018
- Date of Event
- May 1, 2017
- Report Date
- December 21, 2018
- Manufacturer
- TERUMO BCT
- Product Code
- KSB
- UDI-DI
- 05020583300033
- PMA / PMN Number
- BK170098
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
SERIAL NUMBER, MANUFACTURE DATE AND EXPIRY ARE NOT AVAILABLE PER THE CUSTOMER. INVESTIGATION: DURING FOLLOW-UP WITH THE AUTHOR OF THE JOURNAL ARTICLE, IT WAS DETERMINED THAT NO ADDITIONAL INFORMATION OR INDIVIDUAL PATIENT/DONOR INFORMATION WILL BE PROVIDED TO TERUMO BCT. THE AUTHOR DECLINED TO PROVIDE FURTHER DETAILS CONCERNING THESE EVENTS, AND THEREFORE,PER SECTION 4.16.2 OF THE MEDICAL DEVICE REPORTING FOR MANUFACTURERS: GUIDANCE FOR INDUSTRY AND DRUG ADMINISTRATION STATION DOCUMENT ISSUES JULY 9, 2013 ONE MDR WILL BE SUBMITTED FOR EACH IDENTIFIED DEVICE AND FAILURE MODE. PER THE AUTHOR OF THE ARTICLE TERUMO BCT DEVICES ARE NOT BEING SUSPECTED OF CONTRIBUTING TO THE BACTERIAL CONTAMINATION, PATIENT REACTIONS OR DEATHS. THE TERUMO BCT PRODUCTS WERE USED SOLELY AS A MEANS OF COLLECTING PRODUCT FOR THE STUDY. THE NHSBT IN (B)(6) INTRODUCED DIVERSION NATIONALLY IN 2003 AND IMPROVED ARM DISINFECTION IN 2007. IN 2011, NHSBT INTRODUCED SCREENING OF ALL PLATELET COMPONENTS FOR BACTERIA AS A FURTHER RISK REDUCTION MEASURE. THE ARTICLE REPRESENTS THE FIRST 4 YEARS AND 7 MONTHS (FEBRUARY 2011 TO SEPTEMBER 2015) OF THE SCREENING PROGRAM USING AN AUTOMATED MICROBIAL DETECTION SYSTEM. THE ARTICLE CONCLUDED THAT 'IMPLEMENTATION OF BACTERIAL SCREENING OF PLT COMPONENTS WITH THEN HSBT BACT/ ALERT PROTOCOL WAS AN EFFECTIVE RISK REDUCTION MEASURE AND INCREASED THE SAFETY OF THE BLOOD SUPPLY'. ALL SAMPLED PLT PRODUCTS MEET THE STUDY SPECIFICATION OF 2.4X10^11 OR GREATER AND THE WHITE BLOOD COUNT (WBC) IN EACH PRODUCT WAS BELOW 5X10^6. RESULTS PER THE ARTICLE: ACCORDING TO MCDONALD ET AL, FROM "FEBRUARY 2011 TO SEPTEMBER 2015,A TOTAL OF 1,239,029 PLT COMPONENTS WERE SCREENED. INITIAL-REACTIVE, CONFIRMED-POSITIVE, AND FALSE-POSITIVE RATES WERE 0.37, 0.03, AND 0.19%, RESPECTIVELY. FALSE- NEGATIVE CULTURES, ALL WITH STAPHYLOCOCCUS AUREUS, OCCURRED ON FOUR OCCASIONS; THREE WERE VISUALLY DETECTED BEFORE TRANSFUSION AND ONE CONFIRMED TRANSMISSION RESULTED IN PATIENT MORBIDITY. THE NHSBT SCREENING PROTOCOL EFFECTIVELY REDUCED THE NUMBER OF CLINICALLY ADVERSE TRANSFUSION TRANSMISSIONS BY 90%IN THIS REPORTING PERIOD, COMPARED TO A SIMILAR TIME PERIOD BEFORE IMPLEMENTATION. DELAYED TESTING OF 4515 TIME- EXPIRED PLT UNITS AFTER SCREENING REVEALED NO POSITIVES."PRIOR TO INOCULATION, THE PROTOCOL AT THE CUSTOMER SITE WAS, WHILE THE OPERATOR WORE NON-STERILE GLOVES, TO WIPE THE SEPTUM OF THE BOTTLE WITH AN ALCOHOL WIPE. THE COMPONENTS WERE HELD FOR 36-48 HOURS POST COLLECTION, A 16ML SAMPLE WAS TAKEN FROM THE SAMPLING POUCH THAT WAS ATTACHED USING THE TSCD II DEVICE. ALL UNITS WERE TREATED THE SAME APART FROM PEDIATRIC UNITS WHICH WERE POOLED TOGETHER. ALL NEGATIVE RESULTS WERE ADDED THE NHSBT COMPUTER SYSTEM. POSITIVE INITIAL REACTIVE RESULTS FROM THE BACT/ALERT SYSTEM RESULTED IN A HOLD OR RECALL OF THE PRODUCT. ADDITIONAL INVESTIGATION WAS MADE ON THE UNITS THAT WERE ALREADY UNDERTAKEN AT A FACILITY. IT WAS DETERMINED THAT THE SOURCE OF THE CONTAMINATION BASED ON THE SPECIES DISTRIBUTION, WAS SKIN FLORA. PER THE ARTICLE, "AT THE BEGINNING OF THE SCREENING PROCESS, THE PLT PRODUCTS WERE MANUFACTURED AT A RATIO OF 80% APHERESIS TO 20% OF POOLED UNITS (BUFFY COAT DERIVED FROM FOUR DONATIONS), MOVING TO 60% APHERESIS AND 40% POOLED UNITS IN 2015. INITIALLY, ALL PLT PRODUCTS WERE SUSPENDED IN 100% PLASMA, BUT FROM FEBRUARY 2015, THE USE OF PLT ADDITIVE SOLUTION (PAS; SSP1, MACOPHARMA) FOR POOLED UNITS WAS PHASED IN AND ALL MANUFACTURING CENTERS PRODUCED POOLED PLTS SUSPENDED IN 65%:35% (PAS:PLASMA) AS OF JULY 2015. ALL REPORTED MOTHER BAGS WERE SPLIT INTO THERAPEUTIC DOSES AT 3 TO 4 HOURS POST COLLECTION. BUFFY COAT¿POOLED PLTS WERE PREPARED FROM FOUR DONATIONS.""AMONG CONFIRMED POSITIVE POOLED PLT COMPONENTS IN WHICH ALL COMPONENTS (INCLUDING ASSOCIATED RBC UNITS) WERE RETURNED FOR TESTING, 58.2% WERE POSITIVE IN THE INDEX UNIT ALONE AND 33.7% IN BOTH INDEX AND RBC UNITS. IN ALL CASES, BACTERIA WERE DETECTED IN ONLY ONE OF THEFOUR RBC UNITS UNDER TEST. FOR POOLED PLT COMPONENTS WHERE THE INDEX PLT UNIT WAS NOT AVAILABLE FOR TESTING, 78 (40.2%) INCIDENTS OF BACTERIAL CONTAMINATION WERE CONFIRMED BY TESTING OF THE RBC UNITS ALONE."THE DEVICE SERIAL NUMBERS WERE NOT PROVIDED; THEREFORE, ONE YEAR OF SERVICE HISTORY COULD NOT BE REVIEWED. ALL DEVICES MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. BASED ON THE BACTERIAL IDENTIFICATION RESULTS OF THE CONTAMINATED UNITS (74.7% SKIN FLORA, 16.4%OROPHARYNGEAL FLORA, AND 8.9% GUT AND OTHER FLORA), AS WELL AS REVIEW OF THE SPECIES, POSSIBLE SOURCES OF CONTAMINATION INCLUDE INADEQUATE DONOR ARM DISINFECTION PRIOR TO VENIPUNCTURE, POOR MANUFACTURING LABORATORY HYGIENE STANDARDS, INCREASED TIME REQUIREMENTS FOR APHERESIS DONATIONS, THE COMMON PRACTICE OF APHERESIS DONORS CONSUMING SNACKS DURING A COLLECTION, AND UNDERLYING PATHOLOGIES IN ASYMPTOMATIC DONORS. INVESTIGATION IS IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION:CARL MCDONALD, JENNIFER ALLEN, SUSAN BRAILSFORD, ANJANA ROY, JOANNE BALL, RICHARD MOULE, MARIZAVASCONCELOS, RACHAEL MORRISON, AND TYRONE PITT (2017). BACTERIAL SCREENING OF PLATELET COMPONENTS BY NATIONAL HEALTH SERVICE BLOOD AND TRANSPLANT, AN EFFECTIVE RISK REDUCTION MEASURE. TRANSFUSION,57: 1122-1131. DOI:10.1111/TRF.14085.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: ACCORDING TO THE CENTERS FOR DISEASE CONTROL AND PREVENTION, NATIONAL CENTER FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES (NCEZID), DIVISION OF HEALTHCARE QUALITY PROMOTION (DHQP), (B)(6) 2011, BACTERIAL CONTAMINATION OF BLOOD PRODUCTS, ESPECIALLY IN PLATELETS THAT ARE STORED AT ROOM TEMPERATURE, IS THE MOST COMMON INFECTIOUS RISK OF BLOOD TRANSFUSION, OCCURRING IN APPROXIMATELY 1 OF 2000-3000 PLATELET TRANSFUSIONS. GRAM¿POSITIVE BACTERIA NORMALLY FOUND ON THE SKIN, SUCH AS STAPHYLOCOCCUS EPIDERMIDIS OR STAPHYLOCOCCUS AUREUS, ARE THE MOST COMMON BACTERIAL CONTAMINANTS OF BLOOD PRODUCTS. THIS TYPE OF CONTAMINATION IS THOUGHT TO OCCUR WHEN THE BACTERIA ON THE SKIN IS PASSED INTO THE COLLECTED BLOOD THROUGH THE COLLECTION NEEDLE. TO ADDRESS THE RISK OF BACTERIAL CONTAMINATION, EFFECTIVE (B)(6) 2004, THE AABB ADOPTED STANDARD 5.1.1.1 (STANDARDS FOR BLOOD BANKS AND TRANSFUSION SERVICES, 22ND EDITION) THAT REQUIRES ALL ACCREDITED INSTITUTIONAL MEMBERS TO "IMPLEMENT MEASURES TO DETECT AND LIMIT BACTERIAL CONTAMINATION IN ALL PLATELET COMPONENTS." ROOT CAUSE: THE JOURNAL ARTICLE ATTRIBUTED THE BACTERIAL TRANSMISSION TO A PRODUCT CONTAMINATED WITH BACTERIA BY MATCHING THE ORGANISM IN THE PATIENT¿S BLOOD CULTURE TO THE ORGANISM IN THE PRODUCT. SOURCES FOR THE BACTERIAL CONTAMINATION IN THE PRODUCT INVOLVED IN THE BACTERIAL TRANSMISSION, AS WELL AS FOR THE 355 PRODUCTS WHICH TESTED POSITIVE FOR BACTERIAL CONTAMINATION, COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSES OF THE BACTERIAL CONTAMINATION INCLUDE, BUT ARE NOT LIMITED TO:- POST PROCESSING LAB QC SAMPLING/HANDLING/TESTING TECHNIQUES; LEAK IN DISPOSABLE SET DUE TO MANUFACTURING ERROR; INADEQUATE DONOR ARM DISINFECTION PRIOR TO VENIPUNCTURE; UNDERLYING PATHOLOGIES IN ASYMPTOMATIC DONORS CITATION: DISEASES AND ORGANISMS / BLOOD SAFETY / CDC. ((B)(6) 2018). RETRIEVED FROM (B)(6).
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: WHEN USED ACCORDING TO THE TSCDII OPERATOR'S MANUAL, THE WAFERS THAT CUT AND WELD THE TUBING ARE SINGLE-USE AND, AFTER THE STERILE CONNECTING PROCEDURE, ARE AUTOMATICALLY EJECTED FROM THE TSCDII DEVICE. THE DESIGN ALLOWS THE OPERATOR TO ADVANCE THE SINGLE USE WAFER TO CUT THE TUBING, WHEREBY IT MELTS THE TWO ENDS OF THE TUBING FROM THE OPPOSING BAGS AT 300+/-50C, AND THEN PRESSES THE MOLTEN ENDS TOGETHER FORMING A SEAL. THE WELD TIME IS 14 SECONDS. NO MICROBIAL CONTAMINANT CAN WITHSTAND THE TEMPERATURE OF THE TUBING AND THEREFORE, A STERILE CONNECTION IS FORMED. THERE WERE NO ALLEGATIONS OR REPORTS OF TSCDII MALFUNCTIONS OR WELDING ERRORS IN THE ARTICLE. INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: PER TERUMO BCT'S INTERNAL RISK EVALUATION DOCUMENTATION AND THE INFORMATION PROVIDED IN THIS PUBLICATION, THERE IS NO EVIDENCE TO INDICATE THAT THE TRIMA SYSTEM INCLUDING THE TSCD II STERILE CONNECTION DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S BACTERIAL INFECTION. PER TERUMO BCT MEDICAL REVIEW PROCESS THE DEVICE DID NOT CAUSE OR CONTRIBUTE THE BACTERIAL CONTAMINATION. DURING FOLLOW-UP WITH THE AUTHOR OF THE JOURNAL ARTICLE, IT WAS REPORTED THAT THE TSCDII DEVICES ARE USED THROUGHOUT THE PROCESS WITHIN THE CUSTOMER SITE (NHSBT). INVESTIGATION IS IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
DURING A TERUMO BCT REVIEW OF THE TRANSFUSION JOURNAL ARTICLE, ¿BACTERIAL SCREENING OF PLATELET COMPONENTS BY NATIONAL HEALTH SERVICE BLOOD AND TRANSPLANT, AN EFFECTIVE RISK REDUCTION MEASURE.¿ RESEARCHERS: CARL MCDONALD, JENNIFER ALLEN, SUSAN BRAILSFORD, ANJANA ROY, JOANNE BALL,RICHARD MOULE, MARIZA VASCONCELOS, RACHAEL MORRISON, AND TYRONE PITT PERFORMED BACTERIAL SCREENING ON PLATELET (PLT) COMPONENTS IN FIVE REGIONAL NATIONAL HEALTH SERVICE BLOOD AND TRANSPLANT (NHSBT) SITES. THE SITES WERE: (B)(6). THE 50,000 POOLED PRODUCTS (POOLED PRODUCTS WERE MADE FROM FOUR DONATIONS) WERE STERILE CONNECTED USING THE TSCD II DEVICE. THE FOLLOWING BACTERIAL TEST RESULTS FROM POOLED PRODUCTS WERE REPORTED FROM FEBRUARY 2011 TO SEPTEMBER 2015:195 CONFIRMED POSITIVES160 INDETERMINATE POSITIVES 183 INDETERMINATE NEGATIVES DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. THIS DEVICE IS NOT AVAILABLE FOR EVALUATION BY TERUMO BCT. THE AUTHOR OF JOURNAL ARTICLE DECLINED TO PROVIDE PROCEDURAL DETAILS, PATIENT INFORMATION, AND PATIENT OUTCOME/FACTORS.
THE JOURNAL ARTICLE REPORTS 355 BACTERIAL CONTAMINATIONS ARE CONFIRMED POSITIVE AND INDETERMINATE POSITIVE AS REPORTED IN THE ARTICLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1031028 | 3ME-SC203A TSCDII 110V | TSCDII 110V | KSB | TERUMO BCT | 3MESC203A | 05020583300033 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |