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

Model Number DSD-201

Device Problems Inadequate Service (1564); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Bacterial Infection (1735)

Event Date 02/11/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The case states that patient infection was reported and traced back to the facilities' water source.They were unable to determine which system had bacteria growing in the waterlines.It was also reported that the facility did not know when they last performed waterline disinfection on their medivators dsd-201 machines.Medivators dsd-201 recommends the use of a pre-filtration system in addition to a 0.2 micron bacterial-retentive filter as part of the installation requirements of the automated endoscope reprocessor (aer).Waterline disinfection should be completed each time the internal bacterial-retentive, 0.2 micron filter is changed, whenever plumbing is dismantled for service, or at any other time that waterline contamination might be suspected.This facility reported failure to follow these instructions.This facility does not have service agreements with medivators on their aer machines.Thus, there is no medivators in-service or maintenance personnel regularly visiting this facility to monitor reprocessing processes.Medivators records indicate that some aers at this facility are as old as manufactured in 2006.Medivators regional clinical specialists, field service engineers, or sales representatives were contacted and reported they were not informed of the water source contamination or patient infection issue.Medivators technical service department received the call from this facility.After being informed of this issue, they instructed them on the waterline disinfection procedure and maintenance requirements.There is limited information provided regarding the patient infections.This complaint will continue to be maintained within medivators complaint system.

Event Description

The case states that patient infection was reported and traced back to the facilities' water source.They were unable to determine which system had bacteria growing in the waterlines.It was also reported that the facility did not know when they last performed waterline disinfection on their medivators dsd-201 machines.

• Brand Name: 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: 5489805
• MDR Text Key: 39989495
• Report Number: 2150060-2016-00010
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: RAPICIDE HIGH-LEVEL DISINFECTANT