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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
Model Number N/A
Device Problems Failure to Infuse (2340); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/25/2018
Event Type  malfunction  
Manufacturer Narrative
Initial reporter's address: (b)(6). The device was not returned; 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 a prismaflex machine did not deliver calcium chloride to the patient during continuous renal replacement therapy (crrt). The machine did not present an alarm. The reporter stated that five hours after the calcium syringe was changed, it was noted that the full volume (50ml) remained in the syringe. The issue was discovered when the value was not as anticipated during testing (further details not provided). The calcium line was changed from cdk (central dialysis catheter) to cvk (central venous catheter) and the treatment continued without further incident. The prismaflex machine was inspected by local service with no issues found, and is still in use at the clinic. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
Additional information: product code, 510k number. The device was not received for evaluation. The event history log was analyzed and the analysis showed that no calcium was delivered between the change syringe procedure during treatment. A condition where the calcium syringe pump became inactive unexpectedly has been verified; however, the cause of the 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. 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 Key7438763
MDR Text Key106014306
Report Number9616026-2018-00007
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K131516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number107493
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/17/2018 Patient Sequence Number: 1
Treatment
CALCIUM CHLORIDE SYRINGE
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