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

Model Number M150

Device Problems Break (1069); Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)

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

Event Date 04/01/2022

Event Type  malfunction  

Event Description

While trying to disconnect the dialysis tubing from the ecmo circuit, rn was twisting off prismaflex tubing form the ecmo circuit and it was very difficult to twist off.The end of the crrt circuit tubing got stuck and broke off into the stopcock of the pigtail on the ecmo circuit.

• Brand Name: PRISMAFLEX SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 14206148
• MDR Text Key: 290066477
• Report Number: 14206148
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2022

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 Model Number: M150
• Device Catalogue Number: 109990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Sex: Female
• Patient Weight: 92 KG