MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-02 for INTERCEPT BLOOD SYSTEM FOR PLATELETS manufactured by Cerus Corporation.
[46472430]
Cerus medical assessment: a device malfunction cannot be established as the intercept technology does not claim to pathogen reduce (b)(6) viruses. The package insert for the ibs for platelets does not include (b)(6) in the list of viruses shown to be inactivated by the ibs for platelets. Feline calicivirus was evaluated as 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. Cerus medical reviewer assesses this case of transfusion transmitted infection with (b)(6) as serious and possibly related to the transfusion of the pc, however, due to extensive homology between the different strains of (b)(6), deep sequencing may be required to definitively prove homology between the platelet donor and the patient.
Patient Sequence No: 1, Text Type: N, H10
[46472431]
(b)(4) is a spontaneous report that was mentioned by dr (b)(6) (medical director (b)(6)) at a conference in (b)(6) on (b)(6) 2016. The report involved an unknown patient who received an intercept platelet component (pc) on an unknown date in 2015 and experienced (b)(6) infection. Testing concluded a "concordant phylogenetic analysis of strain retrieved" from the donor and recipient. Concurrent medical conditions, concomitant medications and medical history were not reported. Cerus requested further information from the (b)(6). Reporter assessment: the reporter considered the event of (b)(6) infection to have "high imputability" to intercept treated platelet component. Follow-up received on 12-apr-2016: patient identifiers were provided from the associate medical director of the (b)(6). This report involves a (b)(6) year old male with existing condition of haemo-pneumothorax trauma without open wound. The patient received transfusions of 30 red cell concentrates (rcc), 7 fresh frozen plasma (ffp), 2 buffy coat (bc) platelet concentrates and 1 apheresis platelet concentrate between (b)(6) 2015. On (b)(6) 2015, (b)(6) was discovered in setting of acute cholecystitis. After some improvement, further deterioration of liver function was observed. On (b)(6) 2015, the patient's nucleic acid test (nat) for (b)(6) was (b)(6). The (b)(6) test result was then confirmed on (b)(6) 2015. Investigations revealed the patient received transfusions from 46 donations. One donor on (b)(6) 2015 also tested (b)(6). The bc from this (b)(6) donor was used to prepare an intercept bc platelet concentrate which was transfused to the patient on (b)(6) 2016. Additional testing revealed (b)(6) virus of genotype 3f. Direct sequencing showed orf2 sequence homology between the virus in the donor and recipient. Viral load of the donor was reported to be at 3. 48 log copies/ml. Reporter assessment: the reporter assessed the prognosis as "favorable" and with an outcome of "full recovery. " the reporter considered the event of (b)(6) infection to have "high imputability" to intercept treated platelet component. No malfunction of the ibs device was reported. Cerus medical assessment: a device malfunction cannot be established as the intercept technology does not claim to pathogen reduce (b)(6) viruses. The package insert for the ibs for platelets does not include (b)(6) in the list of viruses shown to be inactivated by the ibs for platelets. Feline calicivirus was evaluated as 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. Cerus medical reviewer assesses this case of transfusion transmitted infection with (b)(6) as serious and possibly related to the transfusion of the pc, however, due to extensive homology between the different strains of (b)(6), deep sequencing may be required to definitively prove homology between the platelet donor and the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003925919-2016-00002 |
| MDR Report Key | 5696087 |
| Date Received | 2016-06-02 |
| Date of Report | 2016-06-02 |
| Date of Event | 2015-04-18 |
| Date Mfgr Received | 2016-04-12 |
| Date Added to Maude | 2016-06-02 |
| 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 | 9252886000 |
| Manufacturer G1 | FENWAL FRANCE SAS |
| Manufacturer Street | ETAILLE, 36-400 |
| Manufacturer City | LA CHATRE, |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTERCEPT BLOOD SYSTEM FOR PLATELETS |
| Generic Name | INTERCEPT BLOOD SYSTEM FOR PLATELETS |
| Product Code | PJF |
| Date Received | 2016-06-02 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Other | 2016-06-02 |