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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH POLYFLUX 170H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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GAMBRO DIALYSATOREN GMBH POLYFLUX 170H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number POLYFLUX 170H APAC
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Chest Tightness/Pressure (2463)
Event Date 06/12/2017
Event Type  Injury  
Event Description
Reportedly a patient presented with chest distress and a blood pressure drop while treated with a polyflux 170h dialyzer, necessitating medical intervention (oxygen and dexamethasone was administered) and early treatment discontinuation with blood return. No additional information is available.
 
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Brand NamePOLYFLUX 170H
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 Key6716576
MDR Text Key80117694
Report Number9611369-2017-00062
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 07/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Model NumberPOLYFLUX 170H APAC
Device Catalogue Number112466
Device Lot Number6-4918-H-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2016
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: 07/17/2017 Patient Sequence Number: 1
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