MAUDE Adverse Event Report: RENU MEDICAL, INC MERIT; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number	RM-PIB1000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
New out of the package pressure bags will not fill completely.Setting up for line insertion x2, attempted to inflate pressure bag and unable to fill completely with 2 separate bags."bags will not fill completely with bulb compression." replaced with third out of the package pressure bag that did work.No injury to patient.

• Brand Name: MERIT
• Common Device Name: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): RENU MEDICAL, INC; 5900 36th ave w ste 100; everett WA 98203
• MDR Report Key: 22352607
• Report Number: 22352607
• Device Sequence Number: 8082469
• Product Code: KZD
• UDI-Device Identifier: 00816317022426
• UDI-Public: (01)00816317022426
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2025
• Report Date (Section F): 06/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: RM-PIB1000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2025
• 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 Age: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 06/19/2025