MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP

Model Number ADVIA CENTAUR CP

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center because liquid waste splashed into an operator's eye while the operator was emptying the liquid waste on an advia centaur cp instrument.Siemens labeling, specifically the advia centaur cp operator's guide, provides instructions for emptying the liquid waste container.The following biohazard warning precedes these instructions: "biohazard warning - wear personal protective equipment.Use universal precautions.Refer to appendix a, safety information, for recommended precautions when working with biohazardous materials.Appendix a provides a complete guidance for precautions that should be taken when performing processes on the system".A use error contributed to the operator's exposure to biohazardous material as the operator did not follow the biohazard warning in the operator's guide.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

The customer contacted siemens and stated that liquid waste splashed into an operator's eye while the operator was emptying the liquid waste on an advia centaur cp instrument.The operator was not wearing eye personal protective equipment (ppe).After the operator was exposed to liquid waste, the operator followed the laboratory's operating procedure and rinsed her eye at an eye wash.There are no known reports of additional medical intervention or adverse health consequences due to this event.

• Brand Name: ADVIA CENTAUR CP
• Type of Device: ADVIA CENTAUR CP
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; neuwiesenstrasse 4; registration #: 3008494306; beringen, switzerland 8222 ; SZ 8222
• Manufacturer Contact: christina lam ; 511 benedict avenue; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 11528527
• MDR Text Key: 249064433
• Report Number: 2432235-2021-00074
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: 00630414523286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR CP
• Device Catalogue Number: 10309710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2021
• 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