MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER EXACTAMIX 2400 VALVE SET (24-PORT VALVE ASSEMBLY); SYSTEM/DEVICE, PHARMACY COMPOUNDING

Model Number H938724

Device Problem Defective Device (2588)

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

Event Date 03/22/2022

Event Type  Injury  

Event Description

Over the last week, our organization noticed that our tpns (total parenteral nutrition) bags compounded utilizing the baxter baxa em2400 compounding machine have been cloudy or hazy compared to the normally clear solution in the bags.It was determined through filtration not to be a precipitate and different bag lots and manufacturers were used to rule out a bag issue.Upon investigation of pumping test bags and recording the fluid moving through the machine, it was determined that port 2 of 24 possessed a manufacturing error for item h938724 (baxter 24-port valve assembly) lot 60331319, expires 07/31/2024.This was further confirmed under direct testing of each port of this lot by connecting a syringe with dye and trying to inject each port (only port 2 allowed dye into the line).Depending on what different hospitals or organizations assign to port 2, this could be a potentially harmful error for patient (i.E.Potassium chloride, smoflipid with shellfish allergy, other).Upon recognition of this manufacturing issue, our organization immediately quarantined the affected lot number and confirmed a new, different lot number for this product did not possess the same issue and switched usage to the non-affected product.Our potentially affected patients were contacted and any affected tpn product was returned to our pharmacy and replaced.Patients were assessed for any adverse effects, but to date, none have been reported.Fda safety report id# (b)(4).

• Brand Name: BAXTER EXACTAMIX 2400 VALVE SET (24-PORT VALVE ASSEMBLY)
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; MX
• MDR Report Key: 13901459
• MDR Text Key: 288048197
• Report Number: MW5108510
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• 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: 03/22/2022

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 Operator: Health Professional
• Device Model Number: H938724
• Device Catalogue Number: H938724
• Device Lot Number: 60331319
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening
• Patient Sex: Prefer Not To Disclose