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

Catalog Number 115307

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2019

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 prisma flex m150 set, an external fluid leak from the drain bag was observed.It was reported the drain bag connector was disconnected.The set was replaced to continue treatment and the user was in ¿good condition¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection of the drain bag showed the yellow valve of the drain bag with the set was disconnected.The reported condition was verified.The drain valve passed testing including: valve ability to withstand pressure, bonding strength of the valve to the drain tube (traction test) and valve ability to withstand multiple actuations over a treatment.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the condition could not be determined.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 - MEYZIEU; meyzieu
• MDR Report Key: 8293294
• MDR Text Key: 134876765
• Report Number: 8010182-2019-00025
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K080519
• 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: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: 115307
• Device Lot Number: 18F2002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: PR# 1540140
• Patient Sequence Number: 1