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

Model Number DSD-201

Device Problems Improper or Incorrect Procedure or Method (2017); Device Disinfection Or Sterilization Issue (2909)

Patient Problem Exposure to Body Fluids (1745)

Event Date 02/21/2014

Event Type  No Answer Provided  

Event Description

Medivators aer user facility modified/reprogrammed endoscope reprocessing cycle times themselves to reduce their overall scope turn around time.This adjustment does not meet the reprocessing cycle time requirements, is contrary to the ifus of the aer and disinfectant involved (cidex opa), and may have resulted in improper rinsing and/or high level disinfection of endoscopes.

Manufacturer Narrative

The facility deliberately changed the cycle times for reprocessing endoscopes in the dsd-201 automated endoscope reprocessor.Medivators field service engineer (fse) discovered the programming issue while visiting to do maintenance.The endoscopy department manager/director admitted to changing the length of reprocessing cycle times on the machine because she was unhappy with how long it took to reprocess a scope.The facilities endoscope reprocessing procedure does not follow the dfu of the cidex opa requirements to achieve proper rinsing and/or high level disinfection.The facility does not keep records of the reprocessing of their scopes - the cycle reporting is disabled on the machine so there are no documented print outs of the actual cycles being ran.Without the print-out, there is no evidence of proper or failed disinfection of scope prior to patient use.The facility also turned off the temperature monitoring feature on the dsd-201 machine.There is no way of knowing if the opa was used at the proper temperature of 25 degrees c.The cycle times had been cut in half.Rinse times were set to 30 seconds instead of the manufacturer directions of 60 seconds.With a rinse time this short, the endoscopes would likely still have opa residue on them at the time of patient exposure/use.The fse reported that the department manager/director informed him not to reset the programming even at the risk of patient safety.It is likely this facility will continue to reprogram the machine for a shorter cycle time and continue to risk patient safety.This facility has been contacted by a multitude of medivators personnel.There are no reported cases of patient injury or illness as a result of the operator's failure to follow instructions and the operator's failure to follow safety guidelines put in place by the manufacturer and the fda.This complaint will continue to be monitored within the medivators complaint system.If additional information is received, it will be reviewed upon receipt.

• Brand Name: MEDIVATORS DSD-201
• Type of Device: AUTOMATIC 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 ; 7635533300
• MDR Report Key: 3684578
• MDR Text Key: 4294171
• Report Number: 2150060-2014-00007
• 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: Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/17/2014

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?: No
• Device Operator: Other
• Device Model Number: DSD-201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: 10 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2004
• 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
• Treatment: CIDEX OPA