MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-12 for BCS XP SYSTEM 10459330 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[114153715]
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.
Patient Sequence No: 1, Text Type: N, H10
[114153716]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00057 |
| MDR Report Key | 7683051 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-12 |
| Date of Report | 2018-07-12 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-06-20 |
| Date Added to Maude | 2018-07-12 |
| 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 | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | AM KRONBERGER HANG 3 REGISTRATION NUMBER:3003601075 |
| Manufacturer City | SCHWALBACH, 65824 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BCS XP SYSTEM |
| Generic Name | BCS XP SYSTEM |
| Product Code | GKP |
| Date Received | 2018-07-12 |
| Model Number | BCS XP SYSTEM |
| Catalog Number | 10459330 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING-STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-12 |