MAUDE Adverse Event Report: MEDIVATORS INC HPH 700 HEMOCOR; HIGH PERFORMANCE HEMOCONCENTRATOR

Lot Number	554157
Medical Device Problem Code	Filtration Problem (2941)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via medwatch # (b)(4) that "during bypass, the hemocor hph 700 failed (interior filter malfunctioned) on the hemoconcentrator.Perfusionist changed the hemoconcentrator with no harm to the patient.".
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Multiple attempts have been made to contact the user facility to obtain additional information regarding the reported event however, no response has been received.Without a returned device or additional information regarding the reported event be received from the user facility, a root cause cannot be determined.Steris will submit a follow-up report should additional information be received.No additional issues have been reported.

• Brand Name: HPH 700 HEMOCOR
• Common Device Name: HIGH PERFORMANCE HEMOCONCENTRATOR
• 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 ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 19140497
• Report Number: 2150060-2024-00027
• Device Sequence Number: 7861997
• Product Code: KDI
• UDI-Device Identifier: 00677964011177
• UDI-Public: 00677964011177
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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: Health Professional
• Device Lot Number: 554157
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2022
• 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