BACT/ALERT BPN EU - 279045
Report
- Report Number
- 3002769706-2021-00049
- Event Type
- Malfunction
- Date Received
- October 7, 2021
- Report Date
- October 11, 2021
- Manufacturer
- BIOMÉRIEUX, INC.
- Product Code
- MZC
- PMA / PMN Number
- BK050043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
ON FRIDAY 08 OCT 2021, BIOMERIEUX RECEIVED THE FOLLOWING DATA FROM THE CUSTOMER SANQUIN REGARDING THE COLLECTION AND SAMPLING OF THE BLOOD PRODUCT: TIME WHOLE BLOOD UNITS WERE DONATED BY THE BLOOD DONORS: EIN: (B)(6) : (B)(6) 2021; 17:54 H; EIN: (B)(6) : (B)(6) 2021; 14:27 H; EIN: (B)(6) : (B)(6) 2021; 13:27 H; EIN: (B)(6) : (B)(6) 2021; 18:16 H; EIN: (B)(6) : (B)(6) 2021; 20:32 H. TIME THE MULTIPLE WHOLE BLOOD DONATIONS WERE PROCESSED TO DERIVE THE PLATELETS: EIN: (B)(6) : (B)(6) -2021; 08.03H; EIN: (B)(6) : (B)(6) 2021; 08.13H; EIN: (B)(6) : (B)(6) 2021; 08.19H; EIN: (B)(6) : (B)(6) 2021; 08.04H; EIN: (B)(6) : (B)(6) 2021; 08.25H. TIME THE PLATELETS WERE POOLED FROM THE VARIOUS DONATION PLATELETS: (B)(6) 2021 BETWEEN 11.00 H AND 11:30 H TIME THE SAMPLE WAS REMOVED FROM THE POOLED PLATELET BAGS TO BE TESTED ON THE BACT/ALERT SYSTEM. (B)(6) 2021 AROUND 11:50 H FROM THIS DATA, BIOMEREIUX CONCLUDES THAT THE PLATELETS WERE SAMPLED IN LESS THAN 24 HOURS OF THE BLOOD DONATION, (THE SHORTEST TIME AND THE LONGEST TIME BETWEEN BLOOD DONATION AND PLATELET POOL TESTING WAS, RESPECTIVELY, 15HRS,18MIN AND 22HRS,23MIN). SAMPLING IN LESS THAN 24 HOURS IS NOT IN ALIGNMENT WITH OUR BACT/ALERT BPN AND BPA IFUS WHICH STATES: ¿THE PLATELET SPECIMEN SHOULD BE TAKEN AT LEAST 24 HOURS AFTER COLLECTION TO ALLOW FOR NATURAL PROLIFERATION IN THE PLATELET PRODUCT.". THE PATIENT RECEIVED THE TRANSFUSION WITH THE BLOOD PRODUCT ON (B)(6) 2021. THE INVESTIGATION INTO THIS CASE IS ON-GOING. MORE INVESTIGATION DETAILS WILL BE PROVIDED AS THEY BECOME AVAILABLE.
THIS EVENT WAS REVIEWED/ASSESSED BY BIOMÉRIEUX MEDICAL AFFAIRS DEPARTMENT. BACILLUS CEREUS IS A TOXIN-PRODUCING FACULTATIVE ANAEROBIC GRAM-POSITIVE BACTERIA FOUND IN THE ENVIRONMENT, SOIL, VEGETATION, AND FOODS. IT CAN QUICKLY MULTIPLY AT ROOM TEMPERATURE. BATCH RECORD REVIEW OF BACT/ALERT BPA EU (REF: 279044, LOT: 1056751) AND BPN EU BOTTLE (REF: 279045 LOT: 1057073) SHOWED THERE WERE NO MANUFACTURING ANOMALIES THAT INDICATE A POTENTIAL FAILURE OF THE LOT TO MEET PERFORMANCE SPECIFICATIONS. BIOMERIEUX¿S GCS AND BIOMATH DEPARTMENTS REVIEWED (B)(6) CASE DATA. THERE WERE NO INSTRUMENT FAULTS AND THE GRAPHS WERE CONSISTENT WITH TRUE NEGATIVE BOTTLES. THERE HAVE BEEN NO SIMILAR COMPLAINTS FOR THE BACT/ALERT BPA EU / REF: 279044, LOT: 1056751 AND BPN EU / REF: 279045 LOT: 1057073 IN LAST 12 MONTHS. LITERATURE REVIEW: THE RISK OF SEPSIS-ASSOCIATED WITH ROOM TEMPERATURE STORED PLATELETS IS WELL DOCUMENTED. THE RISK IS STILL PRESENT EVEN AFTER THE IMPLEMENTATION OF PREVENTIVE METHODS. IT HAS BEEN SHOWN THAT 100% OF THE PLATELET TRANSFUSION-ASSOCIATED FATALITIES HAVE OCCURRED WITH PLATELET PRODUCTS THAT HAD BEEN STORED FOR 4 OR 5 DAYS BEFORE THE DAY OF TRANSFUSION (REFERENCE 1,2,3). THE FDA PUBLISHED IN DECEMBER 2020 RECOMMENDATIONS AND GUIDELINES TO CONTROL THE BACTERIAL CONTAMINATION RISKS ASSOCIATED WITH ROOM TEMPERATURE STORAGE OF PLATELET PRODUCTS. THE DOCUMENT RECOMMENDS THAT POOLED PLATELETS PRODUCT HAVE AN EXPIRATION DAY THAT DOES NOT EXCEED 5 DAYS FROM THE DAY OF COLLECTION AND THAT THE 16ML SAMPLE VOLUME DRAWN FROM THE PLATELET PRODUCT FOR CULTURE TO CHECK FOR CONTAMINATION BE COLLECTED NOT BEFORE 36 HOURS TO REDUCE THE RISK OF GETTING FALSE-NEGATIVE CULTURE RESULTS DUE TO A TOO-SMALL NUMBER OF BACTERIA PRESENT IN THE PLATELET PRODUCTION AT THE TIME OF SAMPLING (REFERENCE 4). FOR SAMPLE VOLUME COLLECTED AT =24 HOURS A SECONDARY CULTURE SHOULD BE PERFORMED =DAY 3 OR A SECONDARY RAPID TEST SHOULD BE PERFORMED BEFORE TRANSFUSION OF THE PLATELETS PRODUCT TO MINIMIZE THE RISK OF MISSING GROWTH OF BACTERIAL CONTAMINANT DURING STORAGE OF THE PLATELET PRODUCT AT ROOM TEMPERATURE. THE MANAGEMENT OF ROOM TEMPERATURE STORED WHOLE BLOOD POOLED PLATELETS DIFFERED FROM ONE COUNTRY TO ANOTHER. IN EUROPE, BLOOD ESTABLISHMENTS AND NATIONAL AUTHORITIES HAVE IMPLEMENTED INDIVIDUAL PRECAUTION MEASURES TO MITIGATE THE RISK OF BACTERIAL TRANSMISSION (REFERENCE 5). THE RECOMMENDATION OF DRAWING THE SAMPLE VOLUME FOR BACTERIAL CONTAMINATION AFTER 36 HOURS FROM THE TIME OF COLLECTION, OR SECONDARY CULTURE OR RAPID TESTING IS NOT UNIVERSALLY ACKNOWLEDGED, AND THUS THE RISK OF GETTING FALSE-NEGATIVE CULTURE RESULTS DUE TO A TOO-SMALL NUMBER OF BACTERIA PRESENT IN THE PLATELET PRODUCTION AT THE TIME OF SAMPLING CANNOT BE EXCLUDED. IT HAS BEEN WELL DOCUMENTED THAT FALSE-NEGATIVE RESULTS ASSOCIATED WITH THE PRIMARY CULTURE OF PLATELETS ARE ATTRIBUTED TO LOW CONTAMINATION LEVELS THAT ALLUDE DETECTION DUE TO SAMPLING ERROR (REFERENCE 6, 7). THE BACT/ALERT® BPA AND BACT/ALERT® BPN CULTURE BOTTLES IFU STATES: ¿BACT/ALERT® MICROBIAL DETECTION SYSTEMS MAY BE USED FOR QUALITY CONTROL TESTING OF PLATELETS. THE LABORATORY SHOULD FOLLOW ITS OWN QUALITY CONTROL PROCEDURES FOR THIS USE.¿ USERS CONSIDERING THE BACT/ALERT® MICROBIAL DETECTION SYSTEMS FOR SUITABILITY RELEASE TESTING, SHOULD FIRST CONSULT THE NATIONAL REGULATORY AGENCY FOR REQUIREMENTS AND STUDIES NECESSARY TO SUPPORT THAT RELEASE TESTING. ADDITIONALLY, THE IFU STATES ¿"THE PLATELET SPECIMEN SHOULD BE TAKEN AT LEAST 24 HOURS AFTER COLLECTION TO ALLOW FOR NATURAL PROLIFERATION IN THE PLATELET PRODUCT." TO DATE , THERE IS NO EVIDENCE THAT THE BACT/ALERT BPA AND BPN BOTTLES MALFUNCTIONED TO CAUSE OR CONTRIBUTE TO THE DEATH OF THE PATIENT. HOWEVER, AS A DEATH IS ASSOCIATED WITH A PATIENT WHOSE TESTING/TREATMENT INCLUDED THE USE OF THE BACT/ALERT CULTURE BOTTLES, AS A CONSERVATIVE APPROACH, THIS EVENT IS BEING REPORTED TO (B)(6) AND THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) AS A MALFUNCTION EVENT. BIOMÉRIEUX INVESTIGATION IS ONGOING. DETAILS REGARDING THE EXACT TIME OF SAMPLING ARE BEING SOUGHT FROM THE CUSTOMER. A FINAL REPORT WILL BE PROVIDED UPON INVESTIGATION COMPLETION. REFERENCES: HONG H, ET AL., DETECTION OF SEPTIC TRANSFUSION REACTIONS TO PLATELET TRANSFUSIONS BY ACTIVE AND PASSIVE SURVEILLANCE, BLOOD, 2016; 127(4): 496-502. FATALITIES REPORTED TO FDA FOLLOWING BLOOD COLLECTION AND TRANSFUSION ANNUAL SUMMARY. HTTPS://WWW.FDA.GOV/MEDIA/124796/DOWNLOAD. BENJAMIN RJ, TRANSFUSION-RELATED SEPSIS: A SILENT EPIDEMIC, BLOOD, 2016; 127(4): 380-381. FOOD AND DRUG ADMINISTRATION (FDA). BACTERIAL RISK CONTROL STRATEGIES FOR BLOOD COLLECTION ESTABLISHMENTS AND TRANSFUSION SERVICES TO ENHANCE THE SAFETY AND AVAILABILITY OF PLATELETS FOR TRANSFUSION - GUIDANCE FOR INDUSTRY. DECEMBER 2020. HTTPS://WWW.FDA.GOV/REGULATORY-INFORMATION/SEARCH-FDA-GUIDANCE-DOCUMENTS/BACTERIAL-RISK-CONTROL-STRATEGIES-BLOOD-COLLECTION-ESTABLISHMENTS-AND-TRANSFUSION-SERVICES-ENHANCE. PRAX M, BEKEREDJIAN-DING I, KRUT O. MICROBIOLOGICAL SCREENING OF PLATELET CONCENTRATES IN EUROPE. TRANSFUS MED HEMOTHER. 2019 APR;46(2):76-86. FOOD AND DRUG ADMINISTRATION (FDA). BACTERIAL RISK CONTROL STRATEGIES FOR BLOOD COLLECTION ESTABLISHMENTS AND TRANSFUSION SERVICES TO ENHANCE THE SAFETY AND AVAILABILITY OF PLATELETS FOR TRANSFUSION - GUIDANCE FOR INDUSTRY. DECEMBER 2020. HTTPS://WWW.FDA.GOV/REGULATORY-INFORMATION/SEARCH-FDA-GUIDANCE-DOCUMENTS/BACTERIAL-RISK-CONTROL-STRATEGIES-BLOOD-COLLECTION-ESTABLISHMENTS-AND-TRANSFUSION-SERVICES-ENHANCE. PRAX M, BEKEREDJIAN-DING I, KRUT O. MICROBIOLOGICAL SCREENING OF PLATELET CONCENTRATES IN EUROPE. TRANSFUS MED HEMOTHER. 2019 APR;46(2):76-86. MURPHY WG, FOLEY M, DOHERTY C, ET AL. SCREENING PLATELET CONCENTRATES FOR BACTERIAL CONTAMINATION: LOW NUMBERS OF BACTERIA AND SLOW GROWTH IN CONTAMINATED UNITS MANDATE AN ALTERNATIVE APPROACH TO PRODUCT SAFETY. VOX SANGUINIS. 2008; 95:13-19. PEARCE S, ROWE GP, FIELD SP. SCREENING OF PLATELETS FOR BACTERIAL CONTAMINATION AT THE WELSH BLOOD SERVICE. TRANSFUSION MEDICINE. 2011;21:25-32.5. PRAX M, BEKEREDJIAN-DING I, KRUT O. MICROBIOLOGICAL SCREENING OF PLATELET CONCENTRATES IN EUROPE. TRANSFUS MED HEMOTHER. 2019 APR;46(2):76-86.
ON 22 SEP 2021, (B)(6) CONTACTED BIOMERIEUX TO REPORT A PATIENT DEATH WITH POSSIBLE ASSOCIATION WITH BACT/ALERT® BPA EU (REF: 279044, LOT: 1056751) AND BPN EU BOTTLE (REF: 279045 LOT: 1057073). IMMEDIATE BIOMÉRIEUX COMMUNICATION WAS INITIATED WITH SANGUIN. THE CUSTOMER STATED THE PATIENT DIED ON (B)(6) 2021 AFTER A TRANSFUSION WITH THROMBOPLATELETS WHICH WERE ADMINISTERED ON (B)(6) 2021. THE BACT/ALERT BPA AND BPN BOTTLE RESULTS FOR THE PATIENT WERE NEGATIVE; HOWEVER, BACILLUS CEREUS WAS IDENTIFIED IN THE BLOOD CULTURE FROM THE PATIENT ON (B)(6) 2021. THE PATIENT, A (B)(6) YEAR-OLD FEMALE WITH UNDERLYING HEMATOLOGIC DISORDER, WAS SEEN BY A CONSULTING PHYSICIAN WHO ORDERED A PLATELET TRANSFUSION TO TREAT THE PATIENT'S THROMBOCYTOPENIA. THE PATIENT RECEIVED THE FULL PLATELET PRODUCT THROUGH PERIPHERAL VENOUS CATHETER ON (B)(6) 2021, FROM 12:50 TO 13:20. DURING TRANSFUSION AT 13:00, THE PATIENT COMPLAINED OF SHIVERING, NAUSEA, AND VOMITING. AT 15:40, THE PATIENT'S TEMPERATURE INCREASED TO 40°C (>2-DEGREE RISE IN TEMPERATURE). AT 17:10, 3 BLOOD CULTURE SETS (6 BOTTLES: 3 BPA AND 3 BPN) WERE COLLECTED FROM THE PATIENT. THE RESIDUAL PLATELET PRODUCT LEFT IN THE BAG WAS COLLECTED AND INOCULATED ON A CULTURE PLATE. THE CULTURE RESULTS WERE: ¿ SET 1: AFTER 3H INCUBATION, THE BPN BOTTLE WENT POSITIVE WITH B. CEREUS, AFTER 5H OF INCUBATION, BPA BOTTLE WENT POSITIVE WITH B. CEREUS ¿ SET 2: AFTER 5H INCUBATION, THE BPN BOTTLE WENT POSITIVE WITH B. CEREUS, THE BPA BOTTLE STAYED NEGATIVE ¿ SET 3: AFTER 6H INCUBATION, THE BPN BOTTLE WENT POSITIVE WITH B. CEREUS, AFTER 3H OF INCUBATION, THE BPA BOTTLE WENT POSITIVE WITH B. CEREUS ¿ CULTURE OF THE RESIDUAL PRODUCT GREW B. CEREUS BY THE NEXT MORNING. THE CUSTOMER, (B)(6), STATED THAT THEY REPORTED THIS INCIDENT TO (B)(6) ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER: THE PLATELET PRODUCT WAS MADE ON SEPTEMBER 3, 2021 BY POOLING FIVE (5) WHOLE BLOOD DONATION PRODUCTS COLLECTED ON SEPTEMBER 2, 2021. TWO HOURS AFTER THE PLATELET PRODUCT WAS MADE, A SAMPLE VOLUME OF 15ML WAS INOCULATED EVENLY INTO BPA AEROBIC AND BPN ANAEROBIC BOTTLES. THE EXACT TIMES OF DAY THE WHOLE BLOOD PRODUCTS WERE COLLECTED AND THE 15ML SAMPLE VOLUME DRAWN FROM THE PLATELET PRODUCT ARE UNKNOWN. THUS IT IS UNCLEAR IF THE INOCULATION INTO THE BLOOD CULTURE BOTTLES WAS PERFORMED IN LESS, OR MORE, THAN TWENTY-FOUR (24) HOURS AFTER COLLECTION OF THE WHOLE BLOOD PRODUCT. THE SAMPLE VOLUME WAS DRAWN FROM THE PLATELET PRODUCT LESS THAN 36 HOURS AFTER BLOOD DONATION. (B)(6) FOLLOWS A 7 DAYS STORAGE FOR THEIR PLATELET PRODUCTS. THE PLATELET PRODUCT WAS CLEARED AT 08:57 ON (B)(6) 2021, AND TRANSPORTED TO THE HOSPITAL AT 09:55. THE PLATELET PRODUCT WAS RECEIVED IN THE HOSPITAL AT 11:00 ON (B)(6) 2021. TRANSFUSION OF THE PLATELET PRODUCT BEGAN AT 12:50 SAME DAY. BOTH BACT/ALERT BPA AND BPN CULTURE BOTTLES INOCULATED WITH THE 15ML SAMPLE VOLUME OBTAINED FROM THE WHOLE BLOOD POOLED PLATELET PRODUCT ON (B)(6) 2021 WERE FINAL NEGATIVE AT SEVEN DAYS. THERE WAS NO RESIDUAL PRODUCT RETAINED AT (B)(6) TO DO FURTHER TESTING. (B)(6) RECEIVED BACK ALL RELATED FIVE ERYTHROCYTES (RED BLOOD CELLS) DONATION PRODUCTS AND CULTURED THEM; ALL CULTURES WERE NEGATIVE AFTER SEVEN DAYS. SYSTEM PERFORMANCE VALIDATION STUDIES SUMMARIZED IN THE INSTRUCTIONS FOR USE (IFU) SUPPORT RECOVERY AND DETECTION OF B. CEREUS (ATCC® 11778¿) IN BACT/ALERT BPA (REF 279044) AND BPN (REF 279045) CULTURE BOTTLE WITH LEUKOCYTE-REDUCED PLATELET CONCENTRATES. AS B. CEREUS IS A FACULTATIVE ANAEROBE VALIDATED TO BE RECOVERED IN BOTH BPA AND BPN, IT IS UNLIKELY THAT A FALSE NEGATIVE RESULT WOULD BE OBTAINED IN BOTH BOTTLES. BIOMERIEUX HAS REQUESTED SUBMITTAL OF THE CUSTOMER¿S BACILLUS CEREUS STRAINS; ONCE RECEIVED, THESE STRAINS WILL BE TESTED AS PART OF THE ON-GOING INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1489530 | BACT/ALERT BPN EU - 279045 | BACT/ALERT BPN EU | MZC | BIOMÉRIEUX, INC. | 0001057073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |