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

Catalog Number 107142

Device Problem Air/Gas in Device (4062)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/21/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during continuous renal replacement therapy (crrt) with a prismax machine equipped with a thermax blood warmer and a prismaflex hf1400 set, an air in blood alarm was generated approximately 5h 45minutes into treatment, and the prismaflex hf1400 set appeared to have clotting.Extracorporeal blood was not returned to the patient and a blood transfusion was performed.A new treatment was started and air was once again observed in the prismaflex hf1400 set after a few hours of treatment at which time ¿foam¿ and ¿air in blood¿ alarms were generated.The treatment was ended and the extracorporeal blood was manually returned to patient.No additional information was provided.

Manufacturer Narrative

Additional information added to d4, g4, h3, h6 and h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection observed the presence of air in the return line.The reported condition was verified.The cause could not be determined.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 ; 2242702068
• MDR Report Key: 13825131
• MDR Text Key: 287556173
• Report Number: 8010182-2022-00068
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 107142
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: No
• 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: PRISMAX MACHINE; THERMAX BLOOD WARMER DISPOSABLE
• Patient Outcome(s): Required Intervention