MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (HF); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 107140

Device Problem Air/Gas in Device (4062)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 12/17/2023

Event Type  Death  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient was placed on continuous renal replacement therapy (crrt) with a prismaflex hf1000 set and prismax device and subsequently, the patient ¿coded¿ during treatment.Approximately two and a half hours after starting treatment, the dialysis team was called to bedside.The intensive care unit nurse reported that the crrt set had air in the access line and no alarms were generated.It was further reported that the dialysis team noted ¿a small bit of air¿ in the access line and return line was free of air.No filter defects were noted by the team.The patient was disconnected from the set at the time of dialysis assessment.According to the reporter, per hospital policy, the access line is connected to the patient with 2 stopcocks.One has citrate line infusion via a non- baxter pump and the second has a clamped normal saline bag; the return line is connected with 1 stopcock which has prismasol replacement being infused via the non-baxter pump.It was reported an echocardiogram was performed post code and revealed air bubbles in heart.On an unreported date, the patient passed away.The cause of death was not reported.It was not reported if an autopsy was performed.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX SETS (HF)
• 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 - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18498074
• MDR Text Key: 332701803
• Report Number: 8010182-2023-00558
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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: 107140
• Device Lot Number: 23D0056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/15/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALARIS (NON-BAXTER) PUMP; CITRATE LINE; NORMAL SALINE BAG; PRISMASOL; PRISMAX MACHINE
• Patient Outcome(s): Death