MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX M100; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 106697

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

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

Event Date 03/28/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that part of a prismaflex m100 set had spontaneously detached at the joint above the filter before the deaeration chamber spraying blood in the patient room during treatment.The amount of blood loss was not reported.Air was observed in the filter and the lines were immediately clamped and was stopped.There was no patient injury or medical intervention associated with this event.No additional information is available.

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; however, a picture of the impacted set was provided.The visual inspection did not identify any specific issue on the set.Nevertheless, the reported condition is considered as confirmed.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX M100
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11752242
• MDR Text Key: 249284855
• Report Number: 8010182-2021-00152
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414064556
• UDI-Public: (01)07332414064556(10)
• Combination Product (y/n): Y
• PMA/PMN Number: K041005
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 106697
• Device Lot Number: 20B2323M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.