2008T HD SYS. CDX W/BIBAG BLUE STAR 191126

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for 2008T HD SYS. CDX W/BIBAG BLUE STAR 191126 manufactured by Concord Manufacturing.

MAUDE Entry Details

• Report Number: 2937457-2020-00559
• MDR Report Key: 9898205
• Report Source: COMPANY REPRESENTATIVE,HEALTH
• Date Received: 2020-03-30
• Date of Report: 2020-03-30
• Date of Event: 2020-03-13
• Date Mfgr Received: 2020-03-13
• Device Manufacturer Date: 2019-04-23
• Date Added to Maude: 2020-03-30
• 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: MATTHEW AMARAL
• Manufacturer Street: 920 WINTER ST
• Manufacturer City: WALTHAM MA 02451
• Manufacturer Country: US
• Manufacturer Postal: 02451
• Manufacturer Phone: 7816999758
• Manufacturer G1: CONCORD MANUFACTURING
• Manufacturer Street: DIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE
• Manufacturer City: CONCORD CA 94520
• Manufacturer Country: US
• Manufacturer Postal Code: 94520
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• Generic Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Product Code: KDI
• Date Received: 2020-03-30
• Model Number: 191126
• Catalog Number: 191126
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: MO
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CONCORD MANUFACTURING
• Manufacturer Address: DIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE CONCORD CA 94520 US 94520

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-30