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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAX MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAX MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955558
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/15/2023
Event Type  malfunction  
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone no: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient was treated with continuous veno-venous hemodiafiltration (cvvhdf) using a prismax machine equipped with a thermax blood warmer unit which was deactivated from start of treatment because the patient was hyperthermic.At an unknown time, the patient developed hypothermia.The patient's temperature was checked continuously via vesical temperature probe on the indwelling bladder catheter.The set temperature of thermax blood warmer unit was increased.In doing so, user did not realize that increasing the set temperature had no effect on the blood warmer, though thermax was disabled and not activated by the user.The treatment went on for several hours without the user noticing the thermax was still in off mode.Per the reporter, the device did not malfunction; however, this was "an operator error".There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information added to h3, h6 and h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photographic sample, shows the user increasing the temperature.The reported condition was not verified.However, due to the nature of the provided samples, no further testing could be performed.The most likely cause was the user forgot to select ¿accept¿ when increasing the temperature.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAX MACHINES
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - BROOKLYN PARK
7601 northland drive
n suite 170
minneapolis MN 55428
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key17165129
MDR Text Key318123403
Report Number3003504604-2023-00015
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number955558
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/23/2023
Initial Date FDA Received06/20/2023
Supplement Dates Manufacturer Received07/04/2023
Supplement Dates FDA Received07/21/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
THERMAX BLOOD WARMER UNIT
Patient Age82 YR
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