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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 No Audible Prompt/Feedback (2282); Failure to Infuse (2340)
Patient Problem Injury (2348)
Event Date 07/11/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy (crrt) using a prismaflex control unit, the calcium pump stopped without triggering an alarm. The patient did not receive the calcium infusion for 10 hours. Once the issue was noted, the operator initiated a calcium replacement with an external pump. Treatment was discontinued. It was reported ¿after hours¿ the change calcium syringe button was pushed and the pump ¿work normally¿. There was no report of patient injury associated with this event. No additional information is available.
 
Manufacturer Narrative
A sample was not received for evaluation. The event history log was analyzed and it was noted that during treatment a syringe change procedure was performed six hours after treatment started, another syringe change procedure was performed ten hours later. The analysis revealed that no calcium was delivered between the change syringe procedures. The treatment was continued with the syringe pump running, without any further syringe issue until treatment stopped five hours later due to warning alarm ¿ extremely negative. Ten three hour long simulated treatments with rca anticoagulation and a syringe change within ten minutes of the first self-test were performed on a control unit in the baxter workshop, and no issues were observed during therapy. The reported condition was verified. The cause of the condition 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 Key7848197
MDR Text Key119281377
Report Number9616026-2018-00015
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
Report Date 10/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955052
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/05/2018 Patient Sequence Number: 1
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