MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMASATE; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number 106957

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/01/2021

Event Type  Injury  

Event Description

Patient was getting crrt receiving prismasate 4k 2.5 ca.When preparing the bag of dialysate to be hung, dialysate began actively leaking out of bag from spike adaptor and luer lock area.This happened with 3 different bags from 3 different boxes of prismasate.The prismasate from the leaking bags was not used on the patient and was discarded due to infection risk.Patient never received leaking bags.Product info: barcode: (b)(4).

• Brand Name: PRISMASATE
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 12287652
• MDR Text Key: 265605308
• Report Number: MW5103051
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/04/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2022
• Device Model Number: 106957
• Device Lot Number: 20L15G80
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR