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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH POLYFLUX 210H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO DIALYSATOREN GMBH POLYFLUX 210H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 103580
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemolysis (1886); Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Event Date 03/09/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
This is a report of a patient who experienced clotting of the circuit and potential hemolysis manifested by severe hypotension during use of a polyflux 210h. It was reported by the service technician that these events occurred twice. At least one event happened after 20 minutes of hd therapy. Treatment was ended and the circuit was changed twice, which resulted in a blood loss of 600 ml. The patient recovered after the event. No additional information is available.
 
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Brand NamePOLYFLUX 210H
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO DIALYSATOREN GMBH
holger-crafoord-str. 26
hechingen 72379
GM 72379
Manufacturer (Section G)
GAMBRO DIALYSATOREN GMBH
holger-crafoord-str. 26
hechingen
GM
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6470899
MDR Text Key72088614
Report Number9611369-2017-00030
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K043342
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2019
Device Catalogue Number103580
Device Lot Number66219H01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/07/2017 Patient Sequence Number: 1
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