MAUDE Adverse Event Report: MEDIVATORS ADVANTAGE PLUS; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problems Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problems Chemical Exposure (2570); No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2018

Event Type  Injury  

Manufacturer Narrative

A facility reported that intercept detergent was accidentally added to the alcohol bottle used in their advantage plus automated endoscope reprocessor (aer).It was reported that five endoscopes were reprocessed and used in patient procedures after intercept detergent was added to the alcohol bottle; thus, there is potential that patients were exposed to intercept detergent during procedures.During the alcohol purge phase of the reprocessing cycle in the advantage plus aer, alcohol is injected through the endoscope channels to help purge any residual fluids from the endoscope.It is unknown how much detergent was added to the alcohol bottle.Medivators provided the facility with the intercept detergent safety data sheet (sds).Medivators technical services provided the facility assistance with cleaning out their aer and returning the unit to service after the incident.It is stated in the advantage plus aer user manual, "to prevent the accidental switching of the alcohol and detergent reservoirs, always remove, refill and replace each reservoir bottle separately.Refilling the container with the incorrect fluid may cause the endoscope to be improperly disinfected.Do not use the endoscope on a patient if this occurs." therefore, the facility did not follow the instructions from the user manual.Medivators regulatory followed up with the facility and they reported no patient adverse reactions and no additional medical attention was sought by the five potentially affected patients.This complaint will continue being monitored in medivators complaint handling system.

Event Description

A facility reported that intercept detergent was accidentally added to the alcohol bottle used in their advantage plus automated endoscope reprocessor.It was reported that five endoscopes were reprocessed and used in patient procedures after intercept detergent was added to the alcohol bottle; thus, there is potential that patients were exposed to intercept detergent during procedures.

• Brand Name: ADVANTAGE PLUS
• 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: alex nelson ; 14605 28th ave n; minneapolis, MN 55447 ; 7635094799
• MDR Report Key: 8180300
• MDR Text Key: 130890542
• Report Number: 2150060-2018-00078
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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