MAUDE Adverse Event Report: MED MICHIGAN HOLDINGS, LLC / SURGE CARDIOVASCULAR SURGE CARDIOVASCULAR; MULTIPLE PERFUSION SET

Model Number	PER-1400S
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported over pressurizing free flow with a multiple perfusion set prior to use.No injury or death reported.

• Brand Name: SURGE CARDIOVASCULAR
• Common Device Name: MULTIPLE PERFUSION SET
• Manufacturer (Section D): MED MICHIGAN HOLDINGS, LLC / SURGE CARDIOVASCULAR; 2140 oak industrial drive ne; grand rapids MI 49505
• Manufacturer (Section G): MED MICHIGAN HOLDINGS, LLC / SURGE CARDIOVASCULAR; 2140 oak industrial dr ne; grand rapids MI 49505
• Manufacturer Contact: james wisniewski ; 2140 oak industrial dr ne; grand rapids, MI 49505 ; 6168211323
• MDR Report Key: 23004086
• Report Number: 3017540705-2025-00003
• Device Sequence Number: 15702508
• Product Code: DWF
• UDI-Device Identifier: 00817278010347
• UDI-Public: 00817278010347
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K964200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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
• Operator of Device: Health Professional
• Device Model Number: PER-1400S
• Device Catalogue Number: PER-1400S
• Device Lot Number: 09033-022425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown