MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX M60; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 106696

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 a pediatric patient became hypotensive and experienced tachycardia approximately two hours after starting continuous renal replacement therapy using a prismaflex control unit and a prismaflex m60 filter.The patient was treated with a fluid bolus and one dose of calcium.The patient's condition was reported to have stabilized.On the same day, reported as later in the evening, a check return alarm, immediately followed by a return disconnection alarm and then immediately followed by an air in blood alarm was generated by the prismaflex control unit.No disconnection or air in the return line was observed.The air in blood alarm could not be cleared and the nurse was unable to hit stop during the air in blood alarm.The machine was turned off and the blood was not returned.The amount of blood loss was not reported.The patient was re-connected to a new prismaflex control unit and a new prismaflex m60.Thirty minutes later, the 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

Additional information added to h6 and h10 the device was not returned and the lot number of the device was unknown; therefore, a sample analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX M60
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11290579
• MDR Text Key: 234393007
• Report Number: 8010182-2021-00035
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K041005
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 106696
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/07/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX MACHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR