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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX TPE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX TPE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 107144
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Sweating (2444)
Event Date 11/28/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). 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 a patient being treated with a prismaflex set experienced hypotension, and fell down upon standing up from bed, the patient was pale and was sweating and experienced a short loss of consciousness. It was reported that this event happened at an unspecified length of time after treatment with the prsimaflex set. There was blood restitution. At the time of this report, the patient outcome was not reported. No additional information is available.
 
Manufacturer Narrative
Additional information: 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.
 
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Brand NamePRISMAFLEX TPE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - MEYZIEU
meyzieu
Manufacturer (Section G)
BAXTER HEALTHCARE - MEYZIEU
7, av lionel terray, b.p. 126
meyzieu 69883
FR 69883
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8204790
MDR Text Key131699139
Report Number8010182-2018-00179
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P830063
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number107144
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 Received01/08/2019
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: 12/28/2018 Patient Sequence Number: 1
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