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 Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Blood Loss (2597)

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 to continue with treatment.No additional information is available.

Manufacturer Narrative

B6: patient's at time of treatment was 130/70.The device was not 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 file showed that the treatment was ended due to an occlusion at the top of the filter (most likely a clot) causing a cascade of alarms, including check return alarm, return disconnection alarm and, finally, air in blood.The patient's fluid removal was set to 240 ml/h and changed to 230 ml/h approximately two minutes later, which is quite high considering the patient's weight (17 kg).This could potentially be a contributing factor to the reported hypotensive episode.There was no malfunction observed on the device.The cause of the reported condition could not be determined.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: 11290580
• MDR Text Key: 231574459
• Report Number: 9616026-2021-00005
• 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

• 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
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/07/2021
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 03/25/2021
• 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