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

Catalog Number 115307

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The actual device was not available; however, 3 photographs of the sample were provided for evaluation.The visual inspection of the provided pictures revealed the reported leak at the level of the stopcock.During the investigation of similar complaints, it has been noticed that the leakage on the drain bags occurred mainly after several hours of treatment where the bags were being filled and emptied several times.The filling/emptying cycles generates physical constraints on the bags, near the welding of the exhausting tube, eventually causing pinholes to form and leakage to happen.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.Only one bag is provided within the sets since this bag is the one needed to prime the set and to start therapy.Spare bags have been made available in (b)(4) as of july 2020.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during treatment in the intensive care unit with three units of prismaflex m150, an external fluid leak was observed from the welding near the stopcock.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual device was received for evaluation.Visual inspection of all three impacted drain bags confirmed the reported leak took place at level of the stopcock.The reported condition was verified.The cause was user misuse of the drain bag.It is to be noted that the prismaflex m150 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.Due to an adverse trend of complaints regarding this defect, a nonconformance has been opened to address this issue at the meyzieu plant.During the investigation of similar complaints it has been noticed that the leakage on the drain bags occurred mainly after several hours of treatment, after being filled and emptied several times.The filling/emptying cycles generates physical constraints on the bags, near the welding of the exhausting tube, eventually causing pinholes to form and leakage to happen.However, 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.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 CORPORATION; deerfield IL
• MDR Report Key: 10390813
• MDR Text Key: 223834605
• Report Number: 8010182-2020-00128
• Device Sequence Number: 1
• Product Code: KDI
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115307
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.