MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PERITONEAL DIALYSIS TRANSFER SET; SET, I.V. FLUID TRANSFER

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

Event Date 04/16/2024

Event Type  malfunction  

Event Description

Reporter called to notify the fda that he received a letter from baxter giving instructions on which cleansers can be used (or not used) to clean their transfer sets.The cleansers that he is using are okay.

• Brand Name: PERITONEAL DIALYSIS TRANSFER SET
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 19129083
• MDR Text Key: 340564733
• Report Number: MW5153945
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/16/2024

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male