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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 210H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER POLYFLUX 210H DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955610
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Malaise (2359); Palpitations (2467); Low Oxygen Saturation (2477)
Event Date 02/21/2019
Event Type  Injury  
Manufacturer Narrative
The device was not returned and the lot number is unknown; 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 during treatment with a polyflux 210h set, the patient felt sick, experienced a blood pressure decrease, palpitations and decreased oxygen saturation. It was reported 21 minutes after starting treatment the patient experienced palpitations and a blood pressure (bp) reading of 64/27mmhg. It was reported the oxygen saturation (sp02) was decreased to 92%. The patient was administered 3l oxygen therapy and began treatment with effortil in normal saline, risumic and metligine (no further details). It was reported the patient¿s legs were elevated and the patient was monitored on an electrocardiogram. Seventeen minutes later, hd therapy was discontinued. Treatment was restarted with a non-baxter dialyzer. The patient recovered and was released home. It was reported this was a first time use with the polyflux dialyzer. 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)
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 Key8683356
MDR Text Key147478544
Report Number9611369-2019-00074
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K043342
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number955610
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 Received05/15/2019
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: 06/10/2019 Patient Sequence Number: 1
Treatment
NIPRO FIX 190E; NIPRO NCV-3
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