MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP; SET, I.V. FLUID TRANSFER

Catalog Number H938738

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/30/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter last name: (b)(6).E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an exactamix 500 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked.During the visual inspection of the finished product at the compounding facility, the product was identified to be leaking from the injection port.This occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction: d1, d4: expiration date, d4: unique identifier (udi) #.H11: the actual device and two photographs of the sample were received for evaluation.A visual inspection on the actual sample was performed, and leakage was not easily identified by initial visual inspection.The returned photographs were reviewed, and it was noted that there was a leak from the port 2 spike port bonding area.A functional leak test was performed, and a leak was observed from the spike port bonding area.The reported condition was verified.The cause of the condition could not be determined; however, is most likely due to inadequate or lack of cyclohexanone applied to the spike port cap tube when it was inserted to the spike port during the manufacturing process.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19181465
• MDR Text Key: 341533792
• Report Number: 1416980-2024-01897
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2024

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
• Device Operator: Other
• Device Catalogue Number: H938738
• Device Lot Number: 60439145
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2024
• Initial Date FDA Received: 04/25/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1