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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 Operates Differently Than Expected (2913)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 01/16/2018
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
The customer reported that during a continuous veno-venous hemodiafiltration (cvvh) treatment using a citrate anticoagulation strategy, a patient hypocalcemia occurred, which induced a patient hypotension. The complainant suspected a failure of the calcium syringe pump to explain this patient ionized calcium drop. There was patient involvement. Patient outcome was not reported. Additional information was requested, but is not available at this time.
 
Manufacturer Narrative
The device was evaluated on-site by a field service technician. An inspection of the device was performed and revealed no issues with the device. The treatment history files were reviewed and revealed that two change syringe procedures had been performed, one on the date of the event and one on the date prior to the event. Further analysis revealed that no calcium was delivered between the change syringe procedures. The reported issue could not be duplicated using the current released software. Ten three hour long simulated treatments with rca anticoagulation and a syringe change within ten minutes of the first self-test have been performed on a control unit with no issues noted. A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. The reported condition was verified. The cause of the condition could not be 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
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 Key7289144
MDR Text Key100694433
Report Number9616026-2018-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/22/2018 Patient Sequence Number: 1
Treatment
CALCIUM LINE PRISMAFLEX CA250; PRISMAFLEX HF1400 SET
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