MAUDE Adverse Event Report: MEDIVATORS MEDIVATORS DSD-201; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number DSD-201

Device Problem Device Contamination With Biological Material (2908)

Patient Problem Bacterial Infection (1735)

Event Date 07/11/2014

Event Type  No Answer Provided  

Event Description

Patients infected with bronchial microorganism due to contaminated water source linked with the facilities automated endoscope reprocessor.

Manufacturer Narrative

The case states that the facility contacted medivators because of unspecified microorganism was found in their water system connected with the endoscope reprocessor.They reported that patients were becoming infected after having a bronchoscopy procedures using the scopes reprocessed in the medivators dsd-201 automated endoscope reprocessor (aer).The details were relayed to medivators senior clinical specialist and medivators (b)(4) on the (b)(4) 2014 via phone conference.Medivators concluded that the microorganism was being transferred to the patient by residuals from the contaminated water being left on the scope during the aer rinse cycle.It was confirmed that medivators dsd-201 aers being used at this facility were operating according to specification and had nothing to do with the water being contaminated.Medivators sent the facility decontamination kits.Medivators also advised the facility to check their filter maintenance records, bleed the waterlines, and perform water disinfection.After this call, medivators did not receive any additional details of this case.There is no additional information regarding the current patient status.This complaint will continue to be monitored within medivators complaint system.

• Brand Name: MEDIVATORS DSD-201
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 3995486
• MDR Text Key: 4775287
• Report Number: 2150060-2014-00028
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2010
• 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 Outcome(s): Hospitalization