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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 109990
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)
Event Date 03/22/2018
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. The patient had concomitant medication which included an ace inhibitor. The instructions for use provided with this device specify that patients receiving angiotensin converting enzyme (ace) inhibitors as medication can develop, within the first few minutes of a treatment, symptoms similar to acute allergic reactions i. E bronchospasm, edema of airways or larynx, dyspnea, angioedema, urticaria, nausea, vomiting, diarrhea, respiratory arrest, abdominal cramping, hypotension, hypovolemic shock and death. Therefore, special attention ought to be paid to patients receiving ace inhibitors. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that within 15 minutes of starting therapy on an m150 circuit, the patient developed hypotension, tachycardia, and started wheezing. The patient was receiving an angiotensin converting enzyme (ace) inhibitor at the time of the event. Treatment was stopped and the blood was not returned. Upon discontinuation of treatment, the patient immediately recovered. Therapy was restarted using a different baxter dialyzer. No additional information is available.
 
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Brand NamePRISMAFLEX M150
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 Key7443372
MDR Text Key105937452
Report Number8010182-2018-00034
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080519
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number109990
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/19/2018
Distributor Facility Aware Date03/22/2018
Event Location Outpatient Treatment Facility
Date Report to Manufacturer04/19/2018
Date Manufacturer Received03/22/2018
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: 04/19/2018 Patient Sequence Number: 1
Treatment
ACE INHIBITOR
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