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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - MEYZIEU DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number ASKU
Device Problem No Flow (2991)
Patient Problem Blood Loss (2597)
Event Date 12/28/2020
Event Type  Injury  
Manufacturer Narrative
Brand name: this report is against an unknown prismaflex set. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that clotting was observed in the prismaflex set during continuous renal replacement therapy using a prismax control unit. No ¿warning¿ was generated by the prismax device. There was blood loss and the extracorporeal blood was not returned to the patient. On the following day, the prismaflex filter was changed and clotting recurred. Extracorporeal blood was once again not returned to the patient. It was reported that the patient required a blood transfusion. The patient outcome was not reported. No additional information is available.
 
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Brand NameNI
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - MEYZIEU
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MEYZIEU
7, av lionel terray, b.p. 126
meyzieu cedex rhone 69883
FR 69883
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key11240059
MDR Text Key229584307
Report Number8010182-2021-00020
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/30/2020,03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/30/2020
Event Location Hospital
Date Report to Manufacturer12/30/2020
Date Manufacturer Received02/26/2021
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 Unkown

Patient Treatment Data
Date Received: 01/27/2021 Patient Sequence Number: 1
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