MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 109990

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2021

Event Type  malfunction  

Manufacturer Narrative

Alternate phone number: (b)(6).Address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that within seconds of starting continuous veno-venous hemodiafiltration therapy using a prismax machine and a prismaflex m150 set, an air in blood alarm was generated.The deaeration chamber was observed to have completely filled with foam.Troubleshooting was unsuccessful and the treatment was ended without the extracorporeal blood being returned to the patient.The foam had completely filled the deaeration chamber and return monitor line, reaching the transducer filter and the machine had stopped for 10 minutes.The patient was disconnected without returning the blood.The event was reported twice.There was no patient injury or medical intervention associated with this event.

Manufacturer Narrative

H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX M150
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; deerfield IL
• MDR Report Key: 11738255
• MDR Text Key: 249285754
• Report Number: 8010182-2021-00150
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414090005
• UDI-Public: (01)07332414090005(10)
• Combination Product (y/n): Y
• PMA/PMN Number: K080519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 109990
• Device Lot Number: 20H1303
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAX MACHINE; THERMAX BLOOD WARMER UNIT