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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - LUND MONITORS PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 114870
Device Problem No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the prismaflex machine failed during continuous veno-venous hemodiafiltration (cvvhdf) treatment. The reporter stated that the issue occurred just after the 8. 1 software update. The calcium syringe worked until the first calcium refill, but then no longer moved. The machine did not show any error messages until the user pushed the syringe change button. The calcium was replaced after restarting the prismaflex machine and crrt treatment. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
The device was not received for evaluation. A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. A device history review revealed no issues that could have caused or contributed to the reported issue. The event history log review analysis showed that no calcium was delivered from the change syringe procedure until the treatment was stopped. A condition where the calcium syringe pump became inactive unexpectedly has been verified. The cause of the event was not determined. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - LUND MONITORS
lund skane lan
MDR Report Key7368494
MDR Text Key103728433
Report Number9616026-2018-00004
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 05/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number114870
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

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