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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER REVACLEAR 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER REVACLEAR 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number N/A
Device Problem Fluid Leak (1250)
Patient Problems Fatigue (1849); Nausea (1970); Dizziness (2194); Malaise (2359)
Event Date 11/18/2017
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.
 
Manufacturer Narrative
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during dialysis with a revaclear 400 dialyzer, a small clear puddle of fluid (no blood noted) was coming from the dialyzer. There were 35 minutes remaining in the treatment, from 4 hours 15 minutes of treatment in total. The patient started to feel "unwell". The patient became nauseous, light headed and had delayed speech. The treatment was discontinued immediately by the nurse and blood was returned to the patient. The patient recovered quickly. An unspecified dose of intravenous vancomycin was administered. After the blood was returned, the patient felt better. The patient left the hospital feeling tired but denied any nausea or lightheadedness. The patient's vitals were stable prior to discharge. No additional information is available.
 
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Brand NameREVACLEAR 400
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER
hechingen
MDR Report Key7114495
MDR Text Key282809708
Report Number9611369-2017-00180
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K130039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model NumberN/A
Device Catalogue Number114746
Device Lot Number7-7055-H-01
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/13/2017 Patient Sequence Number: 1
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