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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 No Consequences Or Impact To Patient (2199)
Event Date 08/06/2018
Event Type  malfunction  
Manufacturer Narrative
Reporter telephone number: (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 ¿gently touched¿ the syringe pump and an error message was triggered. The extracorporeal blood was not returned to the patient. Treatment was discontinued. There was no report of patient injury or medical intervention 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 later, another syringe change procedure was performed. This was followed by a malfunction alarm ¿ general system failure (code 6) and malfunction alarm ¿ syringe pump (code 9),and treatment was stopped. The analysis revealed that no calcium was delivered between the change syringe procedures. 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 Key7843050
MDR Text Key119157347
Report Number9616026-2018-00013
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 10/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/04/2018 Patient Sequence Number: 1
Treatment
PRISMAFLEX ST150 SET
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