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U.S. Department of Health and Human Services

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

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MEDIVATORS INC HPH 700 HEMOCOR; HIGH PERFORMANCE HEMOCONCENTRATOR Back to Search Results
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.
 
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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 Key19140497
MDR Text Key341464052
Report Number2150060-2024-00027
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00677964011177
UDI-Public00677964011177
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Number554157
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/18/2024
Date Device Manufactured08/30/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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