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

Catalog Number 114870

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was an excessive delivery of heparin during continuous renal replacement therapy with a prismaflex machine.It was reported that within 15 minutes of starting infusion, 10,000iu of heparin was completely infused to the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Based on the records of the log file, the estimated blood loss of 190 ml wasn¿t returned to the patient.The actual device was inspected on site by a qualified baxter technician.A simulated treatment and a full functional check including the operation of the syringe pump was performed and the device passed.The reported condition was not verified.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.The analysis of the treatment log file did not find any evidence of malfunction of the prismaflex device in the delivery of the anticoagulant fluid.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.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: 10391030
• MDR Text Key: 202429431
• Report Number: 9616026-2020-00020
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114870
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BD PLASTIPAK; BD PLASTIPAK
• Patient Weight: 68