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

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.

• 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 Key: 17165129
• MDR Text Key: 318123403
• Report Number: 3003504604-2023-00015
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• 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 Number: 955558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 07/04/2023
• Supplement Dates FDA Received: 07/21/2023
• 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 Number: 1
• Treatment: THERMAX BLOOD WARMER UNIT
• Patient Age: 82 YR