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

Model Number 955626

Device Problems Display or Visual Feedback Problem (1184); Compatibility Problem (2960)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2023

Event Type  malfunction  

Event Description

For two nights, the crrt machine with #(b)(4) required a work order.The patient's filter pressures were 340 so i returned the blood and began setting up a new filter.Half way through priming the new filter, the machine said that the thermax blood warmer was in transport mode, however it wasn't, nor had it been adjusted all night.I called the customer service number and they said the only thing i could do was discard the set and reboot the machine.After discarding the set and resetting the machine, i began to type the prescription into the machine and a notification popped up that the thermax blood warmer was not linked to the current crrt machine so it could not be used.I called customer service again and they said the machine would need a work order since there was no work around for that notification.They also mentioned that the notification was odd because the thermax was previously working with said machine just an hour prior.I let the health unit coordinator know this information so a work order could be placed.Prismax numbers on the back of the machine: ref # 955626, sn # (b)(6).Manufacturer response for baxter prismax crrt machine, prismax (per site reporter).The manufacturer says it is user error.

• Brand Name: PRISMAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 17198053
• MDR Text Key: 317873727
• Report Number: 17198053
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/12/2023

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 Model Number: 955626
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23360 DA
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White