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

Catalog Number 955433

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2022

Event Type  malfunction  

Event Description

It was reported that the of a prismaflex machine was observed to be "slightly deformed".There was no patient involvement.No additional information is available.

Manufacturer Narrative

Initial reporter information: unknown.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the photos of the device confirmed the reporting of the baxter service engineer which had installed the machine.The stand of the base was bent, and this caused the body of the prismaflex being slightly tilted forward.The device malfunction concluded that the cause of the defect was due to the transport conditions and in particular the package of the device was reversed upside down during the transportation.To resolve the issue, the qualified technician replaced the base.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX MACHINE
• 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 - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15438683
• MDR Text Key: 301566530
• Report Number: 9616026-2022-00091
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123185
• UDI-Public: (01)07332414123185
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NA.