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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 14L DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 14L DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 109651
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Itching Sensation (1943)
Event Date 08/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a hemodialysis patient using a polyflux 14l dialyzer experienced angioedema, hypotension and urticarial rashes 5 minutes into treatment. It was reported that the bloodline and dialyzer were flushed with 700ml of normal saline and circulated with dialysate fluid for at least 10 minutes with pump speed of 200-250mls/min before the start of dialysis treatment. The treatment was discontinued with blood restitution. The patient was treated with adrenaline 0. 5mgx2 im (intra-muscular), intravenous hydrocortisone 200mg, normal saline fluid challenge, blood investigation and intra-nasal oxygen. Most of the symptoms were resolved the following day, except for some residual swelling. No additional information is available.
 
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Brand NamePOLYFLUX 14L
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
hechingen
Manufacturer (Section G)
BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
holger - crafoord - strasse 26
hechingen D-723 79
GM D-72379
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7819287
MDR Text Key118316609
Report Number9611369-2018-00082
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeSN
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 09/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number109651
Device Lot Number8-5118-H-01
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 Received09/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/27/2018 Patient Sequence Number: 1
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