MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2018-12-21 for 3ME-SC203A TSCDII 110V 3MESC203A manufactured by Terumo Bct.
[131310216]
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 england 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 the nhsbt 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 for36-48 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 the four 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 notbe 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.
Patient Sequence No: 1, Text Type: N, H10
[131310217]
During a terumo bct review of the transfusion journal,? 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: bristol, manchester, sheffield, new castle, and london. All 250,000 apheresis plt products were collected on the trima system. A single confirmed report of bacterial transmission was noted by the clinical team associated with a 6-day-old pooled product, which was reported in the screening period. The recipient noted in this report was an elderly neutropenic patient with acute myelogenous leukemia who developed rigors and fever within 15 minutes of the start of the plt transfusion due to contamination with s. Aureus and recovered after prompt treatment. The 50,000 pooled products (pooled products were made from four donations) were sterile connected using the tscd ii device. Due to eu personal data protection laws, the patient information is not available from the customer. The device is unavailable for evaluation by terumo bct. The author of journal article declined to provide additional procedural details, patient information, and patient outcome/factors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2018-00358 |
| MDR Report Key | 8189937 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-21 |
| Date of Event | 2017-05-01 |
| Date Mfgr Received | 2019-02-08 |
| Date Added to Maude | 2018-12-21 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVE KERN |
| Manufacturer Street | 10810 W COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032392246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3ME-SC203A TSCDII 110V |
| Generic Name | TSCDII 110V |
| Product Code | KSB |
| Date Received | 2018-12-21 |
| Model Number | 3MESC203A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT |
| Manufacturer Address | LAKEWOOD CO 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-21 |