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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
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a communication error code 7 alarm occurred on a prismaflex control unit during continuous renal replacement therapy with a pediatric patient connected. Treatment was terminated and the extracorporeal blood was not returned to the patient. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. 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 Key8074605
MDR Text Key127872548
Report Number9616026-2018-00021
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 11/15/2018,12/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2018
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/15/2018
Distributor Facility Aware Date10/20/2018
Event Location Hospital
Date Report to Manufacturer11/15/2018
Date Manufacturer Received11/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

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