MAUDE Adverse Event Report: MEDIVATORS CER-2 OPTIMA; AUTOMATED ENDOSCOPE REPROCESSOR

Model Number CER-2 OPTIMA

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chemical Exposure (2570)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

It was reported the customer installed their cer-2 optima automated endoscope reprocessor incorrectly, resulting in high level disinfectant (hld) being pulled through the machine during the air purge of the endoscope reprocessing cycle.Thus, the potential of residual hld being left which could potentially cause patient chemical colitis.It was confirmed the customer installed their cer-2 optima automated endoscope reprocessor (aer).The aer does not require a medivators personal to install the machine.There was an initial complaint filed by the facility because the aer was receiving leak errors.A medivators field service engineer was called onsite to investigate the complaint and discovered the machine was incorrectly installed by the facility.The cer-2 optima machine was returned to medivators for evaluation and it was confirmed the air tube was hooked up to the hld tank, thus not following the instructions for use (ifu) for install.The facility used their cer-2 optima to reprocess scopes for about two weeks during the time in which their machine was installed incorrectly, thus the potential for patient chemical colitis.They have not had any reports of patient harm.It was reported that some employees felt ill from the hld being leaked into the machine.No information of specific symptoms was reported.The customer has ordered a new machine and will install it with medivators field service engineer present to ensure the ifu is followed.

Event Description

It was reported the customer installed their cer-2 optima automated endoscope reprocessor incorrectly, resulting in high level disinfectant (hld) being pulled through the machine during the air purge of the endoscope reprocessing cycle.Thus, the potential of residual hld being left which could potentially cause patient chemical colitis.

• Brand Name: CER-2 OPTIMA
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447 ; 7635533349
• MDR Report Key: 7575765
• MDR Text Key: 110324200
• Report Number: 2150060-2018-00041
• 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: Replace
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CER-2 OPTIMA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2018
• 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): Other