MAUDE Adverse Event Report: MED MICHIGAN HOLDINGS, LLC / SURGE CARDIOVASCULAR SURGE CARDIOVASCULAR; MULTIPLE PERFUSION SET (NON-STERILE)

Model Number	PER-1400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No pictures or affected product sample were returned.No harm or patient death was reported.No response provided by the customer on location of leak, flow rates/pressure, or whereabouts of the affected sample.Review of manufacturing records for the per-1400, multiple perfusion set (non-sterile) lot 03872-062320 components and finished product all met acceptance with no associated nonconformance's, deviations, or rework / sorts.Manufacturer medline (kit packer) communicated no incidents or issues with this lot of product.There have been no design changes and all applicable design testing reports met acceptance for no leaks.Complaint record review from 2020 to 2024 resulted in no other complaints for lot 03872-062320 for any failure codes.Complaint record review for all multiple perfusion set models resulted in two (2) previous complaints reported for the failure code leaking.However, both previous complaints could not be confirmed or determine cause due to missing information (e.G., unknown lot) and/or no pictures / samples provided.The complaint history yielded no systemic trend.At this time confirmation and cause cannot be determined based upon the record review with no affected sample returned.Therefore, no remedial action is required.
Event or Problem Description
Customer reported perfusion set leaking.No patient injury/death was reported.

• Brand Name: SURGE CARDIOVASCULAR
• Common Device Name: MULTIPLE PERFUSION SET (NON-STERILE)
• 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 drive ne; grand rapids MI 49505
• Manufacturer Contact: james wisniewski ; 2140 oak industrial drive ne; grand rapids, MI 49505
• MDR Report Key: 20370217
• Report Number: 3017540705-2024-00001
• Device Sequence Number: 17857487
• Product Code: DWF
• UDI-Device Identifier: 00817278011092
• UDI-Public: 00817278011092
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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-1400
• Device Catalogue Number: PER-1400
• Device Lot Number: 03872-062320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown