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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 Problems Disconnection (1171); Fluid Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); No Consequences Or Impact To Patient (2199); Loss of consciousness (2418); Blood Loss (2597)
Event Date 08/02/2019
Event Type  Injury  
Manufacturer Narrative
Additional information: it was reported during follow up that the return blood line became disconnected from the patient¿s catheter leading to an unknown amount of blood leaking into the bed. No alarm was allegedly generated. The patient became hypotensive and loss of consciousness resulting in the administration of unspecified ¿blood products¿. At the time of this report, the patient outcome was not reported. 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.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy (crrt) using an unknown prismaflex set, an external blood leak was observed. It was reported the return blood line was disconnected from the patient¿s catheter which led to a blood leak to the bed (volume of blood unreported). There was no report of patient injury or medical intervention associated with the event. 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
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 Key8931080
MDR Text Key162745931
Report Number8010182-2019-00173
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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?
Event Location No Information
Date Manufacturer Received10/01/2020
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: 08/26/2019 Patient Sequence Number: 1
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