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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 955052
Device Problems Failure to Infuse (2340); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). An event history log analysis was performed and showed that no calcium was delivered between the change syringe procedures. The reported condition was verified. The cause of the reported condition could not be determined. A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a prismaflex machine experienced a malfunction general system failure (6). This alarm occurred during patient therapy and while the nurse attempted to change the calcium syringe. The nurse attempted to change the calcium syringe as the patient required an increase of calcium compensation up to 150%. The calcium kept falling and it was noticed that the calcium syringe was still full and was not infused into the patient for 12 hours with no syringe related alarms that occurred. It was further clarified that machine was continued to be in use after the event and working as expected. However, after analysis of the device history logs, it was determined that no calcium was delivered to the patient. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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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
Manufacturer (Section G)
BAXTER HEALTHCARE - LUND MONITORS
magistratsvagen 16
lund skane lan SE-22 643
SW SE-22643
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8092242
MDR Text Key128412476
Report Number9616026-2018-00024
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 11/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955052
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received10/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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