MAUDE Adverse Event Report: CERUS CORPORATION INTERCEPT BLOOD SYSTEM FOR PLATELETS; ILLUMINATOR SYSTEM FOR BLOOD PRODUCTS

Model Number APRL

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2018

Event Type  malfunction  

Event Description

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.

• Brand Name: INTERCEPT BLOOD SYSTEM FOR PLATELETS
• Type of Device: ILLUMINATOR SYSTEM FOR BLOOD PRODUCTS
• Manufacturer (Section D): CERUS CORPORATION; 2550 stanwell dr; concord CA 94520
• MDR Report Key: 8153343
• MDR Text Key: 130508863
• Report Number: 8153343
• Device Sequence Number: 1
• Product Code: PJF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: APRL
• Device Catalogue Number: E8341V00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1