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 Hypovolemic Shock (1917)

Event Date 05/27/2022

Event Type  Death  

Event Description

It was reported that after 32 hours of continuous venovenous hemodiafiltration (cvvhdf) on a prismax machine, it was identified that the operator erroneously entered the pre-blood pump (pbp) flow rate into patient fluid removal (pfr) and set pfr at 1000 ml/h.The reported total fluid withdrawal level was 32 liters.The patient reportedly presented with anuria and circulatory instability due to hypovolemic shock.The patient was transferred to a nearby maximum care facility and ¿entered a health crisis¿ and subsequently passed away shortly afterwards.The cause of death was unknown.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

The serial number of the prismax machines were reported as (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

D4: the involved prismax machines were (b)(6), based on the event history log review.H10: the devices were evaluated on site by a qualified technician: both were found performing within specification and were returned to clinical service.The event history log review showed that the prismax machines behaved as intended and within the specification limits.It is unlikely that a malfunction of the prismax caused or contributed to the serious event of excessive fluid removal requiring medical intervention and subsequent death.The event was caused by a device use error when entering the treatment parameters.A service history review revealed no indication that the parts replaced during servicing caused or contributed 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 ; 2242702068
• MDR Report Key: 15078969
• MDR Text Key: 296342872
• Report Number: 3003504604-2022-00021
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 08/31/2022
• 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 Sequence Number: 1
• Treatment: PHOXILIUM.; PRISMAFLEX M100 SET.; PRISMOCITRATE 18/0.
• Patient Outcome(s): Death
• Patient Age: 53 YR
• Patient Sex: Male