MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 103453

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2018

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 an external leak was observed on a phoenix monitor.It was not specified when in the process of therapy this occurred.It was reported a loose hose was observed by an onsite qualified technician.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Device code 2017 was added.The device was evaluated on site.A functional check was performed and the loose hose observed was due to an operator error.The phoenix operator's manual, a specific warning is present in "external components cleaning", stating that: "careful attention must be paid to dismounting and re-mounting dialysate connectors, concentrate connectors and chemical connectors in order to avoid damages to those components and leakages from those components.The hose was adjusted.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PHOENIX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; medolla modena
• MDR Report Key: 8126500
• MDR Text Key: 129353462
• Report Number: 9616240-2018-00014
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K103832
• 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: 01/17/2019

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: 103453
• Device Lot Number: PH30034
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1