MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST100; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 115309

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

Prismaflex st100 set ckt has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.Initial reporter phone number:  (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during treatment with a prismaflex st100, a leak in the connection between the bag and the stop cock was observed.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information added to b5, h3, h6 and h10.B5: it was reported that the bag had been in use for 12 hours prior to the disconnection of the valve.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.According to the event description, the bag was in use for 12 hours before the disconnection of the valve occurred.Within several hours of treatment, the bag had been filled and emptied several times.The filling/emptying cycles generates physical constraints on the bags.It is to be noted that the prismaflex st100 set ckt set and all the accessories provided within the set, including the drain bag, is a single use product.This means that once used, the product must not be reused (i.E.Emptied and reused during the same therapy) and should be discarded.The prismaflex control unit operator's manual indicates to ¿change fluid bags when the appropriate caution alarm occurs (pbp bag empty, replacement bag empty, dialysate bag empty or effluent bag full)¿.The prismaflex control unit warns the operator when the effluent bag is full, and it is specified in the on-screen instruction delivered by the prismaflex control unit that the drain bag should be disconnected and changed for a new bag.The cause of the event was identified as user error of the effluent bag.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX ST100
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11216588
• MDR Text Key: 228835659
• Report Number: 8010182-2021-00007
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414118389
• UDI-Public: (01)07332414118389
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 115309
• Device Lot Number: 20G1203
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1