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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 Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the drain bag was leaking during treatment involving a prismaflex m150.The leakage was detected in the intensive care unit during patient treatment and was observed from the level of the pouch welding near the stopcock.When this issue was found, the user replaced the device with a new product to continue the treatment.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information : the device was received for evaluation.The sample analysis confirmed that there was a leak at the welding of the bag near the stopcock.The reported condition was verified.The cause was related to manufacturing process.The reported issue is being further investigated.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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
Manufacturer (Section G)
BAXTER HEALTHCARE - MEYZIEU
7, av lionel terray, b.p. 126
na
meyzieu cedex rhone 69883
FR   69883
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8151411
MDR Text Key130983180
Report Number8010182-2018-00163
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K080519
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/30/2019
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 Expiration Date06/01/2020
Device Catalogue Number115307
Device Lot Number18F2002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/15/2018
Initial Date FDA Received12/11/2018
Supplement Dates Manufacturer Received01/21/2019
Supplement Dates FDA Received01/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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