• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Pump (1502); Failure to Infuse (2340); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2017
Event Type  malfunction  
Manufacturer Narrative
The device was returned to a baxter workshop for analysis. The treatment history files were reviewed and revealed that two change syringe procedures had been performed on the date of 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 the control unit in the baxter workshop with no issues noted. A device history review revealed no issues that could have caused or contributed to the reported issue. 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. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
The customer reported that during treatment with a prismaflex machine, a malfunction of the calcium syringe occurred. The treatment type was regional citrate anticoagulation. The syringe containing calcium was replaced as planned. The calcium was to be delivered at approximately 8-9 ml/hr. However, approximately six hours after the syringe replacement, the supervising nurse found that the syringe was still full and therefore no calcium was delivered to the patient via the linear pump during this time interval. The nurse exchanged the syringe using the "change syringe" routine and found out that after this procedure, calcium was once again delivered in a regular manner. The treatment was switched to another prismaflex control unit later the same day. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 22643
SW 22643
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7074640
MDR Text Key261994356
Report Number9616026-2017-00065
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeEZ
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,Followup
Report Date 02/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2017
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 No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/12/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-