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 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that six (6) exactamix 500 ml eva (ethylene-vinyl acetate) tpn (total parenteral nutrition) bags leaked from an unspecified location.This occurred during setup, prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction: this report is a duplicate of manufacturer report number 1416980-2024-01709.All information can be found under manufacturer report number 1416980-2024-01709.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: 19126197
• MDR Text Key: 341010574
• Report Number: 1416980-2024-01759
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477220
• UDI-Public: (01)00085412477220
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: 60462369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 05/02/2024
• 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