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 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The actual device was not available; however, a photograph of the sample was provided for evaluation.The picture only revealed the filter's label.The reported condition was verified.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.Therefore based on the above, the cause identified for the reported events is an unintended use of the effluent bag.A nonconformance has been opened at the plant to address these reported issues.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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 a prismaflex m150, an external fluid leak was observed from the welding next to the stopcock.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: PRISMAFLEX M150
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10406628
• MDR Text Key: 222021402
• Report Number: 8010182-2020-00130
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: TW
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• 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: 20D1505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1