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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 106697
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 01/03/2019
Event Type  Death  
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that after continuous veno-venous hemofiltration (cvvh), using a prismaflex m100 set, an intensive care unit patient experienced a cardiac arrest and subsequently passed away. It was reported two minutes after starting therapy the patient became restless and asked for therapy to be discontinued. Fifteen minutes after starting therapy an extreme negative pressure alarm was generated. Fifteen minutes later therapy was discontinued. Eighteen minutes after therapy was discontinued, the patient was unresponsive and three minutes after the patient experienced cardiac arrest and passed away. During treatment, citrate was provided and there were no coagulation issues. There was no report of a medical intervention associated with this event. The cause of death was reported as due to cardiac arrest. It was not reported if an autopsy was performed. 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. The patient¿s comorbidities of critical condition with septic shock, acute cardiac failure and paroxysmal atrial fibrillation, have been assessed as contributing factors to the patient¿s death. Upon further investigation, no malfunction was reported on the prismaflex m100; therefore, the prismaflex m100 is no longer considered suspect in this event. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NamePRISMAFLEX M100 SET
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - MEYZIEU
meyzieu cedex rhone
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 Key8471235
MDR Text Key140545435
Report Number8010182-2019-00090
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/01/2019,05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number106697
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/01/2019
Distributor Facility Aware Date03/08/2019
Event Location Hospital
Date Report to Manufacturer04/01/2019
Date Manufacturer Received05/02/2019
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: 04/01/2019 Patient Sequence Number: 1
Treatment
PRISMAFLEX CONTROL UNIT
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