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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 Dyspnea (1816); Chest Tightness/Pressure (2463)
Event Date 09/19/2017
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 patient undergoing treatment with a polyflux 14l, experienced chest tightness and shortness of breath. This happened forty minutes into treatment. The patient was immediately treated with 5 mg of dexamethasone intravenously, oxygen was administered and the blood flow was reduced. The symptoms were improved after ten minutes, treatment was discontinued and the extracorporeal blood was returned to the patient. Continuous clinical monitoring was ongoing. After thirty minutes of clinical observation, the patient was treated with 5mg of dexamethasone, treatment was initiated to completion. No additional information is available.
 
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.
 
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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
MDR Report Key7877764
MDR Text Key120312818
Report Number9611369-2018-00107
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 11/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number109651
Device Lot Number7-5109-H-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/14/2018 Patient Sequence Number: 1
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