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

Catalog Number 955792

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Blood Loss (2597); Bronchospasm (2598)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

Facility name: (b)(6) hospital.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that within 30 minutes of restarting continuous renal replacement therapy with a new prismaflex control unit, a pediatric patient experienced bronchospasm, hypotension and tachycardia in the 160s.The pre blood pump prescription was increased and the patient was given a fluid bolus and two doses of calcium.The patient's condition stabilized.Shortly afterwards, "the patient was at full flows on the circuit per prescription" and the patient began to show clinical signs of change.Approximately twenty minutes later, the machine alarmed with return disconnection and filter clotting.At this time, the patient started seizing, experienced bradycardia, and became hypotensive.At this time, the patient's pupils were observed to be fixed and no pulse was palpable.Treatment was terminated and blood was not returned to the patient.Amount of blood loss was not reported.Cardiopulmonary resuscitation was performed for 45 minutes before the patient stabilized and was placed on extracorporeal membrane oxygenation.No additional information is available.

Manufacturer Narrative

B6: patient's at time of treatment was 130/70.H10: the device was received for evaluation.A device history review of complaints and service reports of the last 24 months revealed that the device had previous reported events of self-test failure alarm (code 4).The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.There was no malfunction observed on the device.The cause of the reported condition could not be determined.The 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
• MDR Report Key: 11290581
• MDR Text Key: 231575447
• Report Number: 9616026-2021-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K131516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955792
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX M60
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR
• Patient Weight: 17