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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 170H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 170H; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 112466
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Nausea (1970); Vomiting (2144); Abdominal Distention (2601)
Event Date 01/09/2019
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, within 10 minutes of starting therapy with a polyflux 170h, the patient experienced ¿ants crawling sensation¿, a little difficulty breathing, abdominal distension, nausea and vomiting, reported as "for two times".The treatment was discontinued and the patient was treated with dexamethasone 10 mg (intravenous injection) and adrenaline 1 mg (subcutaneous injection).The patient was connected to a new dialyzer to continue with treatment.After 10 minutes of restarting treatment, the symptoms disappeared.The treatment was successfully completed four hours later and the patient went home.No additional information was provided.
 
Manufacturer Narrative
Additional information: adverse event problem.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
POLYFLUX 170H
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
hechingen
MDR Report Key8327508
MDR Text Key135875967
Report Number9611369-2019-00011
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K043342
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number112466
Device Lot Number8-4918-H-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/14/2019
Initial Date FDA Received02/11/2019
Supplement Dates Manufacturer Received02/12/2019
Supplement Dates FDA Received02/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age43 YR
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