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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); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Vomiting (2144); Tingling (2171); Dizziness (2194); Malaise (2359); Palpitations (2467); Abdominal Distention (2601)
Event Date 01/30/2019
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
It was reported that 10 minutes into treatment with a polyflux 170h dialyzer, a hemodialysis patient experienced a tingling sensation, body unwell, difficulty breathing, hoarse voice, abdominal distension, nausea, vomiting (twice), dizziness and low blood pressure (90/60 mmhg). It was reported the blood was returned and treatment was discontinued. A 50% glucose injection, 60 ml intravenous injection and infusion of 0. 9% saline water 500ml was administered without improvement. It was reported an allergic reaction was suspected and dexamethasone 10 mg intravenous injection and adrenaline 1 mg subcutaneous injection were administrated. Two minutes later, the patient felt better, reported as ¿smooth breathing, voice recover, still felt dizzy¿, blood pressure was110/70mmhg. Five minutes later the patient experienced palpitations and an unspecified 60 mg intravenous injection and dopamine 200 mg intravenous infusion were administered. It was reported the ¿palpitations calmed down¿ after the adrenaline 1 mg; ¿however, patient experienced obvious dizziness and lack of movement¿. Blood pressure was reported as 100/60 mmhg with dopamine. Subsequently, the patient was admitted to the intensive care unit. The patient was discharged five days after hospital admission. At the time of this report, the patient outcome was not reported. 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)
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 Key8418737
MDR Text Key138753169
Report Number9611369-2019-00027
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 03/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2021
Device Catalogue Number112466
Device Lot Number8-4918-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 Received02/18/2019
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: 03/13/2019 Patient Sequence Number: 1
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