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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEMOCONCENTRATOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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MAQUET CARDIOPULMONARY GMBH HEMOCONCENTRATOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number BC 20 PLUS
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2021
Event Type  malfunction  
Manufacturer Narrative
A follow up medwatch will be submitted when further information becomes available.
 
Event Description
It was reported that there is blood leakage occurred while using hemoconcentrator. The failure was found to have no effect on the patient. Complaint id: #(b)(4).
 
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Brand NameHEMOCONCENTRATOR
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
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MDR Report Key12566977
MDR Text Key274428186
Report Number8010762-2021-00537
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K123288
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/18/2021
Device Model NumberBC 20 PLUS
Device Catalogue Number70102.9558
Device Lot Number92268457
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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