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

Lot Number 554157

Device Problem Filtration Problem (2941)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

Event 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.".

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

• Brand Name: HPH 700 HEMOCOR
• Type of Device: 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
• MDR Text Key: 341464052
• Report Number: 2150060-2024-00027
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00677964011177
• UDI-Public: 00677964011177
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Lot Number: 554157
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Date Device Manufactured: 08/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1