MAUDE Adverse Event Report: IMMUCOR, INC. GALILEO ECHO; AUTOMATED BLOOD BANK SYSTEM

Catalog Number	0087000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019 immucor advised customer advised that all waste products must be treated as potentially infectious material as you would treat any blood products.On (b)(6) 2019 immucor directed the affected individual to the instruction in the echo operator manual which states "always wear protective gloves and clothing when handling blood samples, liquid waste, used micro-well strips, or consumed liquid reagent vials.All blood samples, liquid waste, used micro-well strips, and consumed liquid reagent vials must be discarded following the standard practice of the laboratory." the immucor internal report record number for this report is pr#(b)(4).
Event or Problem Description
On (b)(6) 2019 customer reported that an operator was splashed in the eyes with potentially infectious material while removing waste reservoir from echo instrument.No injury reported but medical follow-up was sought after exposure.

• Brand Name: GALILEO ECHO
• Common Device Name: AUTOMATED BLOOD BANK SYSTEM
• Manufacturer (Section D): IMMUCOR, INC.; 3130 gateway drive; norcross GA 30091 5625
• MDR Report Key: 9349199
• Report Number: 1034569-2019-00148
• Device Sequence Number: 2352074
• Product Code: KSZ
• UDI-Device Identifier: 10888234001584
• UDI-Public: 10888234001584
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK170132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 0087000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2019
• Initial Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR