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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVATORS INC. HEMOCOR HPH400 HEMOCONCENTRATOR

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MEDIVATORS INC. HEMOCOR HPH400 HEMOCONCENTRATOR Back to Search Results
Model Number HPH 400
Device Problem Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4), distributor of hemocor hemoconcentrators, reported on behalf of a user facility that while using a medivators hph 400 hemoconcentrator, a pediatric patient lost about 100 ml of blood. It was reported that after unclamping the effluent line, the patient blood was sucked to the wall of the waste container as a result of a fiber leak. The patient did not experience any symptoms as a result of the blood loss, there was no delay in the procedure and no medical intervention was required. The hemoconcentrator was returned to medivators for quality assurance investigation. The reported fiber leak was confirmed. Medivators remains in close contact with terumo. This complaint will continue to be monitored in the medivators complaint handling system.
 
Event Description
(b)(4), distributor of hemocor hemoconcentrators, reported on behalf of a user facility that while using a medivators hph 400 hemoconcentrator, a pediatric patient lost about 100 ml of blood. There was no effect on the patient.
 
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Brand NameHEMOCOR HPH400
Type of DeviceHEMOCONCENTRATOR
Manufacturer (Section D)
MEDIVATORS INC.
14605 28th ave n
minneapolis MN 55447
Manufacturer (Section G)
MEDIVATORS INC.
14605 28th ave n
minneapolis MN 55447
Manufacturer Contact
sadie martin
14605 28th ave n
minneapolis, MN 55447
MDR Report Key7857354
MDR Text Key119643921
Report Number2150060-2018-00060
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K923139
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberHPH 400
Device Lot Number883617
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/07/2018 Patient Sequence Number: 1
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