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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Dyspnea (1816); Palpitations (2467)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced nausea, shortness of breath and an increase in heartrate during acute treatment using a prismaflex machine.It was reported that a 4-way high flow stopcock (non baxter product) was used and there was "torn air" in the stopcock resulting to the patient symptoms.The patient was disconnected from the machine immediately and recovered quickly.No additional information is available.

Manufacturer Narrative

Additional information added to h6 and h10: the sample 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.The prismaflex operator manual recommends to not connect additional devices between the return line and the blood access device.The following warning messages are present: always connect the return line directly to the blood access device.Do not connect additional devices between the return line and the blood access device.The use of additional devices, such as three-way valves, stopcocks, or extension lines, may impair return pressure monitoring.Their use can impede the detection of return disconnections, potentially resulting in severe blood loss.Air may enter into the extracorporeal circuit at connection points downstream of the air detector if pressures are negative.Ensure that the patient's blood return connection is firmly secured.Do not connect additional devices between the return line and the blood access device.

• 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: 9328466
• MDR Text Key: 184629223
• Report Number: 9616026-2019-00058
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 12/15/2019
• Supplement Dates FDA Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4-WAY HIGH FLOW STOPCOCK; PHOXILIUM; PRISMAFLEX SET; PRISMOCITRATE
• Patient Outcome(s): Other