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

Catalog Number 113081

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/07/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported approximately 16 hours into a pediatric continuous renal replacement therapy (crrt) in hemodiafiltration (cvvhdf) mode (connected to extracorporeal membrane oxygenation circuit), with a prismaflex control unit and two (2) units of prismaflex hf20 clotted resulting in a blood loss.The amount of blood loss was not specified.Treatment was restarted two and a half hours later with a new prismaflex hf20.Nine hours into treatment, the filter clotted resulting in an unspecified amount of blood loss.Treatment was restarted again on a new prismaflex hf20.On the following day, reported as seventeen hours into treatment, the filter clotted resulting in an unspecified amount of blood loss.It was reported that the prismaflex control unit generated a malfunction: self-test failure code 2, code 4, and code 6 alarms.The patient required packed red blood cells transfusion for the event.The outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information: h3, h6 and h10.H10: the event history log review of the pressure readings showed that clotting alarms were caused by; oscillations of the access and return pressure due to changes of the flows of the ecmo circuit and the natural progressive increase of the pressure drop along the filter (difference between return and filter pressure) determined by building of protein/lipid deposits in the capillaries.The machine was technically assessed by a qualified local service engineer and found to be working within the specification limits.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX
• 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 - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12507400
• MDR Text Key: 272541117
• Report Number: 9616026-2021-00049
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K110823
• 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: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 113081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• 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: PRISMAFLEX HF20; PRISMAFLEX HF20
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Sex: Male
• Patient Weight: 10 KG