MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-11 for INTERCEPT BLOOD SYSTEM FOR PLATELETS APRL E8341V00 manufactured by Cerus Corporation.
[130508863]
Incident #1: platelet pheresis product started leaking near port (ie, without manipulation) while on the platelet rotator. Manufacturer's name: american red cross using cerus product, product identifier: (b)(4), product type: aprl, product code: e8341v00. Incident #2: platelet pheresis product started leaking at port (ie, without manipulation) upon receipt from the blood supplier. Manufacturer's name: american red cross using cerus product, product identifier: (b)(4), product type: aprl, product code: e8341v00.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8153343 |
| MDR Report Key | 8153343 |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-10-13 |
| Report Date | 2018-12-11 |
| Date Reported to FDA | 2018-12-11 |
| Date Reported to Mfgr | 2018-12-11 |
| Date Added to Maude | 2018-12-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INTERCEPT BLOOD SYSTEM FOR PLATELETS |
| Generic Name | ILLUMINATOR SYSTEM FOR BLOOD PRODUCTS |
| Product Code | PJF |
| Date Received | 2018-12-11 |
| Model Number | APRL |
| Catalog Number | E8341V00 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CERUS CORPORATION |
| Manufacturer Address | 2550 STANWELL DR CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-11 |