MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-06-14 for INTERCEPT BLOOD SYSTEM FOR PLASMA manufactured by Cerus Corporation.
[77649974]
Cerus medical reviewer has insufficient information to concur with the reporter's assessment that the event of "(b)(6) viral infection" was likely due to transfusion of intercept blood system (ibs) treated plasma components. (b)(6) is a non-enveloped single-stranded rna virus approximately 27-34 nm in diameter belonging to the genus (b)(6) virus in the (b)(6) family. (b)(6) has been recognized since 2004 as a transfusion-transmissible infectious agent. The seroprevalence and incidence of (b)(6) in the general population and blood donors in european countries indicate an underestimated risk for transfusion transmissions. The spread of (b)(6) among a population can be assessed by determination of antibodies of the igg class against (b)(6). Using this method, epidemiological data have been obtained from several european countries: in (b)(6), the seroprevalence of (b)(6) has been reported to be (b)(6) in the rural population, and to be somewhat, but not significantly, higher in pig farmers ((b)(6). The annual incidence of (b)(6) in the general population in (b)(6) was estimated to be (b)(6). (b)(6) rna was detected in (b)(6) blood donors. In another study, out of (b)(6) were found per year to have detectable (b)(6) rna. The rate of (b)(6) donations was reported to be (b)(6). In this case, the patient may have been infected by the oral route after eating contaminated food, or may have received contaminated plasma. The donors have not been screened for (b)(6) viremia, therefore causality by transfusion cannot be established. A device malfunction cannot be established as the intercept technology does not claim to inactivate (b)(6) viruses. The package insert for the ibs for plasma does not include (b)(6) on the list of viruses shown to be inactivated by ibs for plasma. Feline calicivirus was evaluated as a model for (b)(6)and demonstrated low levels of inactivation. (b)(6), a similar non-enveloped virus, is resistant to inactivation using amotosalen/uva light. Due to extensive homology of the different strains of(b)(6), deep sequencing may be required to definitively prove homology between plasma donors and the patient. Confirmed clinical cases of transfusion transmitted (b)(6) have been documented previously with blood products treated with the ibs system. Cerus concludes that this case represents a possible case of transfusion transmitted (b)(6) that was severe in nature, and if a donor had been shown to be viremic at the time of donation, transfusion transmission would have been an anticipated event. Olsen b, axelsson-olsson d, thelin a, weiland o. Unexpected high prevalence of igg-antibodies to (b)(6) virus in (b)(6) pig farmers and controls. Scand j infect dis. 2006;38:55-58. [pubmed]. Faber ms, wenzel jj, jilg w, et al. (b)(6) virus seroprevalence among adults, (b)(6). Emerg infect dis. 2012;18:1654-1657. [pmc free article] [pubmed]. Vollmer t, diekmann j, johne r, et al. Novel approach for detection of (b)(6) virus infection in (b)(6) blood donors. J clin microbiol. 2012;50:2708-2713. [pmc free article] [pubmed]. Juhl d, baylis sa, blumel j, et al. Seroprevalence and incidence of (b)(6) virus infection in (b)(6) blood donors. Transfusion 2013; 10. 1111/trf. 12121. [pubmed]. Baylis sa, gartner t, nick s, et al. Occurrence of (b)(6) virus rna in plasma donations from (b)(6) and the united states. Vox sang. Hauser l, roque-afonso am, beyloune a, simonet m, deau fb, burin des rn, et al. (b)(6) transmission by transfusion of intercept blood system-treated plasma. Blood. 2014; 123: 796-797. [pubmed].
Patient Sequence No: 1, Text Type: N, H10
[77649975]
Date reported: 18-apr-2017, 13-may-2015, 15-may-2017 (ini). Case (b)(4) is a spontaneous report received on 18-apr-2017 from a physician in (b)(6), and further communications, including a copy of the (b)(6) transfusion reaction report, were received on 13-may-2015 and 15-may-2017. The report involves a (b)(6) year old male patient who received intercept treated fresh frozen plasma and experienced an adverse event of (b)(6) viral infection due to transfusion [pt: transfusion-transmitted infectious disease]. The patient's primary disease is thrombotic thrombocytopenic purpura (ttp). Concurrent conditions, concomitant medications and medical history were not provided. On an unspecified date in (b)(6) 2017, the patient received more than 200 units of pathogen inactivated fresh frozen plasma (ffp) (provided by (b)(6) at a (b)(6) hospital for the treatment of thrombotic thrombocytopenic purpura (ttp). It was reported that the plasma exchange was performed through several transfusions. From (b)(6) 2017, during care received from a private clinic, the patient's treating physician identified an increase in his transaminases levels. This raised concern for acute (b)(6) infection which prompted rna (ribonucleic acid) testing. On an unspecified date in (b)(6) 2017, rna tests (realstar (b)(4) rt-pcr kit) yielded a (b)(6) result for (b)(6). The treating physician concluded that the patient's infection was due to the (b)(6) as the patient did not receive any other blood products in their clinic. The physician assessed that the infection seemed very likely due to the plasma exchange that was performed in (b)(6) at the (b)(6) hospital. On (b)(6) 2017 (18:37h), (b)(6) was notified of the patient's (b)(6) result. On (b)(6) 2017, a (b)(6) transfusion reaction report was submitted to (b)(6) by the hemovigilance officer at the private clinic in which the (b)(6) test result was confirmed. Reporter assessment: the hemovigilance officer assessed the event of "(b)(6) viral infection due to transfusion [pt: transfusion-transmitted infectious disease]" as grade 3 (severe) in severity. The physician considered the causality for the event to be grade 3 (likely) in relation to the transfused plasma component. Cerus medical review: cerus medical reviewer has insufficient information to concur with the reporter's assessment that the event of "(b)(6) viral infection" was likely due to transfusion of intercept blood system (ibs) treated plasma components. (b)(6) is a non-enveloped single-stranded rna virus approximately 27-34 nm in diameter belonging to the genus (b)(6). (b)(6) has been recognized since 2004 as a transfusion-transmissible infectious agent. The seroprevalence and incidence of (b)(6) in the general population and blood donors in european countries indicate an underestimated risk for transfusion transmissions. The spread of (b)(6) among a population can be assessed by determination of antibodies of the igg class against (b)(6). Using this method, epidemiological data have been obtained from several european countries: in (b)(6), the sero prevalence of (b)(6) has been reported to be (b)(6) in the rural population, and to be somewhat, but not significantly, higher in pig farmers ((b)(6). The annual incidence of (b)(6) in the general population in (b)(6) was estimated to be (b)(6). (b)(6) rna was detected in (b)(6) blood donors. In another study, out of (b)(6) were found per year to have detectable (b)(6) rna. The rate of (b)(6) donations was reported to be (b)(6). In this case, the patient may have been infected by the oral route after eating contaminated food, or may have received contaminated plasma. The donors have not been screened for (b)(6), therefore causality by transfusion cannot be established. A device malfunction cannot be established as the intercept technology does not claim to inactivate (b)(6) viruses. The package insert for the ibs for plasma does not include (b)(6) on the list of viruses shown to be inactivated by ibs for plasma. Feline calicivirus was evaluated as a model for (b)(6) and demonstrated low levels of inactivation. (b)(6), a similar non-enveloped virus, is resistant to inactivation using amotosalen/uva light. Due to extensive homology of the different strains of (b)(6), deep sequencing may be required to definitively prove homology between plasma donors and the patient. Confirmed clinical cases of transfusion transmitted (b)(6) have been documented previously with blood products treated with the ibs system [6]. Cerus concludes that this case represents a possible case of transfusion transmitted (b)(6) that was severe in nature, and if a donor had been shown to be viremic at the time of donation, transfusion transmission would have been an anticipated event. Olsen b, axelsson-olsson d, thelin a, weiland o. Unexpected high prevalence of igg-antibodies to (b)(6) virus in (b)(6) pig farmers and controls. Scand j infect dis. 2006;38:55-58. [pubmed]. Faber ms, wenzel jj, jilg w, et al. (b)(6) virus seroprevalence among adults, (b)(6). Emerg infect dis. 2012;18:1654-1657. [pmc free article] [pubmed]. Vollmer t, diekmann j, johne r, et al. Novel approach for detection of (b)(6) virus infection in (b)(6) blood donors. J clin microbiol. 2012;50:2708-2713. [pmc free article] [pubmed]. Juhl d, baylis sa, blumel j, et al. Seroprevalence and incidence of (b)(6) virus infection in (b)(6) blood donors. Transfusion 2013; 10. 1111/trf. 12121. [pubmed]. Baylis sa, gartner t, nick s, et al. Occurrence of (b)(6) virus rna in plasma donations from (b)(6) and the united states. Vox sang. Hauser l, roque-afonso am, beyloune a, simonet m, deau fb, burin des rn, et al. (b)(6) transmission by transfusion of intercept blood system-treated plasma. Blood. 2014; 123: 796-797. [pubmed].
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003925919-2017-00001 |
| MDR Report Key | 6642421 |
| Report Source | FOREIGN |
| Date Received | 2017-06-14 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-03-16 |
| Date Mfgr Received | 2017-04-18 |
| Date Added to Maude | 2017-06-14 |
| 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 | CAROL MOORE |
| Manufacturer Street | 2550 STANWELL DRIVE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal | 94520 |
| Manufacturer Phone | 9258766819 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERCEPT BLOOD SYSTEM FOR PLASMA |
| Generic Name | INTERCEPT BLOOD SYSTEM FOR PLASMA |
| Product Code | PJF |
| Date Received | 2017-06-14 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERUS CORPORATION |
| Manufacturer Address | 2550 STANWELL DRIVE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-14 |