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

Model Number 1-2-610.002

Device Problem Misassembly During Maintenance/Repair (4054)

Patient Problem Bacterial Infection (1735)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

During an inspection of the facility's advantage plus pass-thru automated endoscope reprocessor (aer), a cantel medical field service engineer (fse) identified that the dosing lines for rapicide pa part b were interchanged between the aer left and right basins.The aer connections were corrected by the fse and testing was performed to ensure the machine was functioning properly.Since the original report, the user facility has informed medivators that five patients have been diagnosed with pseudomonas infections.The user facility also reported that it is not certain if the reported infections are due to use of the endoscopes reprocessed in their aer.Based on the information provided and the investigation of the complaint, cantel has confirmed that a human error occurred and the dosing lines for rapicide pa part b were interchanged between the aer left and right basins.The cause of this situation is expected to be due to incorrect connections during a previous servicing event with the aer.

Event Description

During an inspection of the facility's advantage plus pass-thru automated endoscope reprocessor (aer), a cantel medical field service engineer (fse) identified that the dosing lines for rapicide pa part b were interchanged between the aer left and right basins.The aer connections were corrected by the fse and testing was performed to ensure the machine was functioning properly.Since the original report, the user facility has informed medivators that five patients have been diagnosed with pseudomonas infections.The user facility also reported that it is not certain if the reported infections are due to use of the endoscopes reprocessed in their aer.

• Brand Name: ADVANTAGE PLUS PASS-THRU
• 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: mitchell cole ; 9800 59th ave n; plymouth, MN 55442 ; 7638984338
• MDR Report Key: 10891980
• MDR Text Key: 217956319
• Report Number: 2150060-2020-00017
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K172677
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1-2-610.002
• Device Lot Number: 1000052316
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2020
• 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