MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2018-07-30 for BACT/ALERT? BPA 279018 manufactured by Biomerieux Inc..
[115359012]
A medical device report was submitted by biomerieux to the fda regarding the occurrence in california referenced in describe event or problem. Reference mdr # 3002769706-2017-00296.
Patient Sequence No: 1, Text Type: N, H10
[115359013]
During a post-market surveillance review of a journal article titled "fatal sepsis associated with bacterial contamination of platelets - utah and california, august 2017," discrepant results were identified associated with bact/alert? Bpa (reference 279018). The journal article states that two (2) patients in utah expired after platelet transfusions from the same donation. Patient 1: clostridium perfringens isolates from one patient's blood. "in august 2017, two (2) apheresis platelet units and one (1) unit of plasma were manufactured from an apheresis blood donation in utah. Both platelet units were distributed to hospital x, where a male (patient 1) with acute myeloid leukemia and neutropenia received one of the platelet units. Thirty (30) minutes after transfusion, he developed rigors; transfusion-transmitted bacterial infection was not considered then because of the patient's complex medical history. The patient died four (4) days later. Anaerobic blood cultures, obtained shortly after transfusion, grew c. Perfringens five (5) days after collection. " patient 2: patient's platelet bag and donor skin swabs were highly related by whole genome sequencing (wgs). "fourteen (14) hours after patient 1's transfusion, a female patient (patient 2) with acute myeloid leukemia received the other platelet unit while on broad-spectrum antibiotics for neutropenia at hospital x. No immediate symptoms of sepsis followed transfusion. Later that day, routine laboratory testing revealed new intravascular hemolysis. Transfusion-transmitted bacterial infection was suspected, and gram stain of platelet bag residuals was performed revealing gram-positive bacilli; the platelet supplier was immediately notified. Patient 2 died eleven (11) hours after transfusion. C. Perfringens was isolated from an anaerobic culture of the residual platelets. Post transfusion blood cultures from patient 2 were negative. " an investigation will be initiated by biom? Rieux.
Patient Sequence No: 1, Text Type: D, B5
[128617654]
An internal biom? Rieux investigation was performed with results as follows: a review of the manufacturing direction was not able to be performed for the events that occurred in (b)(6) as the article did not contain specific information regarding the bottles or lot numbers. No issues with bact/alert? Bpa culture bottle (p/n 279018) lot 1048428 or with the manufacturing process was found. Bact/alert? Bpa culture bottle ifu 9300540 a - 2010/12 was reviewed by the investigator for the appropriate user instructions. The following caution is in the reagents section of the ifu: "bact/alert bpa culture bottle test procedure: preliminary comments and precautions: for best overall recovery when culturing platelet specimens, it is strongly recommended that more than one type of culture bottle be utilized (e. G. , one aerobic and one anaerobic). Laboratory procedure: negative cultures may be checked by smear and/or subculture at some point prior to discarding as negative. Note: a report of "negative" should not be interpreted as meaning that the original product is sterile. The negative status could be due to under-inoculation of the bottle, no organisms present in the inoculum, the number of organisms were too small for detection, or a culture bottle/medium that does not support the growth of the organism. For best overall recovery when culturing platelet specimens it is strongly recommended that more than one type of culture bottle be utilized (e. G. , one aerobic and one anaerobic). Note: for quality control testing of platelets, the culture bottle should be held through the expiration date of the product (the platelet unit with the shortest expiration date in the six (6) unit pool will determine the final expiration of the pool. ) or until designated positive. The platelet specimen should be taken at least 24 hours after collection to allow for natural proliferation in the platelet product. " the ifu provides sufficient caution and instructions to the user regarding platelet specimens and negative results. Root cause: on 05sep18 the cross-functional team (cft) consisting of quality assurance (qa), global customer service (gcs), and research and development (r&d) and industrialization discussed the nature of the complaint and the details provided by the article surrounding the events and the information provided in the ifu. The article states that the pathogen might have been detected with the modified culture strategy which is not routinely practiced in the united states. Platelet units were screened for bacterial contamination using an aerobic culture only. Failure to screen platelet units anaerobically risks missing contamination by obligate anaerobes. "clostriduim" perfringens would not be expected to be recovered in an aerobic culture such as the bpa bottle. The root cause was not identified in the article but recommends blood suppliers enhance safety interventions to reduce further the risk for bacterial contamination of platelets. Trend review: no trend was identified similar in nature to the content of the complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2018-00115 |
| MDR Report Key | 7730938 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2018-07-30 |
| Date of Report | 2018-09-26 |
| Date Mfgr Received | 2018-09-13 |
| Date Added to Maude | 2018-07-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOMERIEUX INC. |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27712 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BACT/ALERT? BPA |
| Generic Name | BACT/ALERT? BPA |
| Product Code | MZC |
| Date Received | 2018-07-30 |
| Catalog Number | 279018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX INC. |
| Manufacturer Address | 100 RODOLPHE STREET DURHAM NC 27712 US 27712 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-07-30 |