MAUDE Adverse Event Report: GAMBRO INDUSTRIES PRISMAFLEX SET; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number M100

Device Problems Failure to Disconnect (2541); Physical Resistance/Sticking (4012)

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

Event Date 09/13/2022

Event Type  malfunction  

Event Description

Rn tried to disconnect effluent line from y-connecter to connect to effluent bag but effluent line was stuck on y connector despite multiple tries by different people to disconnect.

• Brand Name: PRISMAFLEX SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO INDUSTRIES; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15484827
• MDR Text Key: 300564568
• Report Number: 15484827
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414064556
• UDI-Public: (01)07332414064556
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M100
• Device Catalogue Number: 106697
• Device Lot Number: 22A0088CB
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3650 DA
• Patient Sex: Male