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

Catalog Number 109990

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problems Air Embolism (1697); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/21/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that at an unknown time during continuous renal replacement therapy using a prismaflex control unit and a prismaflex m150 set, one of the m150 blood lines became disconnected from the bard power trialysis dialysis catheter.This reportedly resulted in about 500 ml blood loss as well as air embolism.No additional information is available.

Manufacturer Narrative

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.

Manufacturer Narrative

Correction: b4/f8: date of this report in the initial mdr is being corrected from blank to 06/21/2021.

• Brand Name: PRISMAFLEX M150
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12033064
• MDR Text Key: 259599472
• Report Number: 8010182-2021-00201
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414090005
• UDI-Public: (01)07332414090005
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

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 Expiration Date: 07/31/2022
• Device Catalogue Number: 109990
• Device Lot Number: 20H1203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 07/21/2021; 07/01/2021
• Supplement Dates FDA Received: 07/23/2021; 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BARD POWER TRIALYSIS DIALYSIS CATHETER.; PRISMAFLEX MACHINE.
• Patient Outcome(s): Other