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 Patient Involvement (2645)

Event Date 06/17/2020

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 priming with three prismaflex m150 sets, external fluid leakage from the effluent bags were observed.It was reported no alarm was triggered.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A leak test was performed and a leak at the level of the drain valve.Was observed.During filling, the drain valve finally gave out.The reported condition was verified.The cause was misuse of the bag.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.It is to be noted that the prismaflex m150 set ckt and all the accessories provided within the set, including the drain bag, is a single use product.If the bag was in use for several hours, the bag had been filled and emptied several times.The filling/emptying cycles generates physical constraints on the bags.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.Only one bag is provided within the sets since this bag is the one needed to prime the set and to start therapy.Since therapy duration and prescribed doses vary for each patient and therapy, replacement bags are provided by baxter as spare bags.

• 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: 10258607
• MDR Text Key: 198360671
• Report Number: 8010182-2020-00085
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.