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

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2019

Event Type  malfunction  

Manufacturer Narrative

The reported product is an unknown prismaflex set.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous veno-venous hemodiafiltration (cvvhdf), using a prismaflex set, an air in blood alarm occurred.It was reported air entrained into the access line.The automated air removal procedure was performed, clearing the alarm twice; however, the alarm continued.It was reported the alarm was overridden and the filter clotted alarm occurred.Foam was observed in the deaeration chamber, the return monitor line, and the line from the top of the filter to the chamber.It was reported 5-6" of foam in the access line near the blood pump was observed.The patient was disconnected and the set was changed.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• MDR Report Key: 8609564
• MDR Text Key: 145115244
• Report Number: 8010182-2019-00126
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/14/2019,06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2019
• Distributor Facility Aware Date: 04/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2019
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX CONTROL UNIT.