MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 107640

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that approximately six to eight hours after starting treatment with six (6) units of prismaflex st150 set, a drip in the bags was observed. The leak was located on the sides and top of the bag. An opening at the top of the bag was identified. There was patient involvement, however, there was no patient injury, medical intervention, or adverse reaction is associated with this event. No additional information is available.

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. 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. 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. Based on the above, the main root cause identified for the reported events is an unintended use of the effluent bag. Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX ST150
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10710362
• Report Number: 8010182-2020-00221
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 107640
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No