MAUDE Adverse Event Report: MEDIVATORS, INC. RAPICIDE PA HIGH LEVEL DISINFECTANT AND STERILANT

Model Number	ML02-0117
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that an employee was exchanging rapicide pa high-level disinfectant/sterilant bottles in the advantage plus automated endoscope reprocessor (aer) and reported inhalation exposure to the disinfectant fumes.The employee sought medical assessment.The user facility did not disclose if medical treatment was determined to be required or administered.It was confirmed that the employee was able to return to work.
Additional Manufacturer Narrative
Details of the products subject of the event were not provided to medivators.Further information regarding the event date, patient symptoms and duration of symptoms were not disclosed.Additionally, the use of ppe and the presence of sufficient environmental ventilation were not able to be confirmed.Medivators reached out to the user facility for further information on the event and to request product return for evaluation.To date, the user facility has not provided a response.The potential for user exposure to occur during disinfectant bottle exchange in the aer is a known hazard.Therefore, the following language can be found in the advantage plus aer operator manual (50097-429, rev j) on page 21 and 63 regarding ppe requirements when exchanging disinfectant bottles: "warning: avoid possible chemical burns.When replacing disinfectant, wear personal protective equipment (clothing, mask, gloves and eyewear." additionally, the rapicide pa high-level disinfectant/sterilant sds (50095-116, rev a) includes the following language regarding ppe and exposure control measures to be taken by users of the disinfectant, "use only outdoors or in a well-ventilated area and wear protective gloves/protective clothing/eye protection/face protection." no additional reports of adverse event or harm were received.No malfunctions of the reported aer and/or disinfectant was able to be confirmed.A follow-up mdr will be submitted should additional information be made available.
Additional Manufacturer Narrative
Details of the products subject of the event were not provided to medivators.Further information regarding the event date, patient symptoms and duration of symptoms were not disclosed.Additionally, the use of ppe and the presence of sufficient environmental ventilation were not able to be confirmed.Medivators reached out to the user facility for further information on the event and to request product return for evaluation.To date, the user facility has not provided a response.The potential for user exposure to occur during disinfectant bottle exchange in the aer is a known hazard.Therefore, the following language can be found in the advantage plus aer operator manual (50097-429, rev j) on page 21 and 63 regarding ppe requirements when exchanging disinfectant bottles: "warning: avoid possible chemical burns.When replacing disinfectant, wear personal protective equipment (clothing, mask, gloves and eyewear." additionally, the rapicide pa high-level disinfectant/sterilant sds (50095-116, rev a) includes the following language regarding ppe and exposure control measures to be taken by users of the disinfectant, "use only outdoors or in a well-ventilated area and wear protective gloves/protective clothing/eye protection/face protection." no additional reports of adverse event or harm were received.No malfunctions of the reported aer and/or disinfectant was able to be confirmed.A follow-up mdr will be submitted should additional information be made available.
Event or Problem Description
The user facility reported that an employee was exchanging rapicide pa high-level disinfectant/sterilant bottles in the advantage plus automated endoscope reprocessor (aer) and reported inhalation exposure to the disinfectant fumes.The employee sought medical assessment.The user facility did not disclose if medical treatment was determined to be required or administered.It was confirmed that the employee was able to return to work.
Additional Manufacturer Narrative
The steris legal department was contacted regarding a legal complaint that had been filed involving rapicide pa high level disinfectant.We reviewed our records and confirmed the event is the same event which was reported in mdr 2150060-2021-00029, filed december 14, 2021.A follow-up mdr will be submitted should additional information become available.

• Brand Name: RAPICIDE PA HIGH LEVEL DISINFECTANT AND STERILANT
• Common Device Name: HIGH LEVEL DISINFECTANT
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442
• MDR Report Key: 13002497
• Report Number: 2150060-2021-00029
• Device Sequence Number: 4292037
• Product Code: FEB
• UDI-Device Identifier: 00677964090172
• UDI-Public: 00677964090172
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: ML02-0117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown