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 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

(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 m150 set, an external leak that ¿dripped to the floor¿ was observed from the drain bag.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, a video of the sample was provided for evaluation.The visual inspection of the provided video revealed the leak to be coming from the level of the stopcock.The reported condition was verified.The cause was user error related.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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.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 taiwan as of july 2020.A nonconformance has been opened to at the plant to address these reported complaints.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: 10329231
• MDR Text Key: 202360713
• Report Number: 8010182-2020-00097
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• 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: 20C1205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.