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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 115307
Device Problems Crack (1135); Improper Flow or Infusion (2954)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).The sample was not returned and the lot number of the device was unknown; therefore, a sample 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 prismaflex m150, air was observed inside the tubing.It was suspected that the luer of the access circuit was cracked.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAFLEX M150
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - MEYZIEU
meyzieu cedex rhone
MDR Report Key9192108
MDR Text Key190156586
Report Number8010182-2019-00195
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K080519
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number115307
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/19/2019
Initial Date FDA Received10/15/2019
Supplement Dates Manufacturer Received09/19/2019
Supplement Dates FDA Received10/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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