MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BCS XP SYSTEM

Model Number BCS XP SYSTEM

Device Problem Flushing Problem (1252)

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

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

While decontaminating the rinse container of the bcs xp system at a customer's site, the customer service engineer (cse) poured micro clean solution and barbicide concentrate down the same sink.The odor and gas released by the reaction between these substances irritated the cse's eyes and throat.The cse flushed the sink continuously with water for 15 minutes and indicated that only he was impacted by the odor emitted from the reaction of these substances.There was no indication of system malfunction.The cause of the event is related to the cse's method when pouring the micro clean solution and barbicide concentrate down the same sink.The system is performing according to specifications.No further evaluation of this device is required.

Event Description

While decontaminating the rinse container of a bcs xp system at a customer's site, a siemens customer service engineer (cse) poured micro clean solution and barbicide concentrate down the same sink.The cse reported that the reaction between these substances produced an odor and gas, which caused irritation to his eyes and throat.No medical treatment or intervention was required.There are no known reports of adverse health consequences due to the reaction between the micro clean solution and barbicide concentrate.

• Brand Name: BCS XP SYSTEM
• Type of Device: BCS XP SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; am kronberger hang 3; registration number:3003601075; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 7683051
• MDR Text Key: 114153715
• Report Number: 9610806-2018-00057
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 00630414945514
• UDI-Public: 00630414945514
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970431
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BCS XP SYSTEM
• Device Catalogue Number: 10459330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 82