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

Model Number CER-1

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 10/03/2014

Event Type  No Answer Provided  

Event Description

The case states that the facility was reprocessing endoscopes in a medivators cer automated endoscope reprocessor with out water and then using the scopes on patients.Potential risk of patient chemical colitis.

Manufacturer Narrative

The case states that the facility was reprocessing endoscopes in the cer autmoated endoscope preprocessor with water turned off.This facility proceeded in using the endoscopes for a reported 12 patient procedures.If the machine cycled without water, the endoscope would have been coated with high level disinfectant and not rinsed.The endoscopes were soaked in disinfectant.The facility reported that the machine did not alarm notifying them that the water was not on.They also reported that the scope smelt really bad and was sticky after opening the lid to the machine.The scopes were still used on patients.The cer machine does have a fluid level alarm that is supposed to sound if a proper fluid level isn't reached within a programmed amount of time.Medivators technical service department followed up and confirmed the fluid level alarm was operating properly.Medivators field service engineer also spoke with this facility to address this issue.He reported that the facility did not follow up with the patients who received procedures with the contaminated scopes.He also reported that the unit has been out of use for more than a year prior to this incident.The evidence indicates that this incident was a result of the facilities maintenance deficiency and failure to follow the manufacturers ifu.There is risk of inadequate rinsing and chemical colitus.To date, there has not been any reported illness or injury.This complaint will continue to be maintained within medivators complaint system.

• Brand Name: MEDIVATORS CER-1
• Type of Device: AUTEOMATED 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: 4196078
• MDR Text Key: 5154495
• Report Number: 2150060-2014-00042
• 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: 10/23/2014

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?: Yes
• Device Operator: Other
• Device Model Number: CER-1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• 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