MAUDE Adverse Event Report: MEDIVATORS CER-1; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number CER-1

Device Problem Inadequate Filtration Process (2308)

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

Event Date 10/05/2016

Event Type  No Answer Provided  

Manufacturer Narrative

The facility reported that they did not have a 0.2 micron absolute bacteria retentive water filter as required in the water filtration system for a medivators cer automated endoscope reprocessor.There is potential for contaminated water being used in the reprocessing of endoscopes, thus potential for waterborne bacteria to be left on the scope during the rinsing cycle.This could result in patient infection.Medivators technical service has been in contact with this facility and they have been informed of the cer filtration requirements.Medivators has shipped them the filtration system for their cer machines for them to install.To date, there have been no reports of patient illness or injury.This complaint will continue to be maintained within the medivators complaint system.

Event Description

The case states that the facility did not have the 0.2 micron absolute bacteria retentive water filter as required in the water filtration system for a medivators cer automated endoscope reprocessor.There is potential for contaminated water used in the reprocessing of endoscopes and potential for waterborne bacteria to be left on the scope during the rinsing cycle, which could potentially affect the patient.

• Brand Name: CER-1
• 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: 6071238
• MDR Text Key: 58932381
• Report Number: 2150060-2016-00044
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K871712
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CER-1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2004
• 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