MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2H7462

Device Problems Material Discolored (1170); Use of Device Problem (1670)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

Since (b)(6) of 2022 (b)(6) has been noting discolored iv tubing from baxter, this has occurred with 4 different types of tubing sets.The discoloration impacts clinical practice as it makes it difficult for the rn administering the iv solution/medication to see the fluid in the tubing, assess for air bubbles, particulate, etc.Infection control and clinical staff have expressed concern utilizing the discolored tubing while caring for the institute's high-risk patient population as they fear the tubing is contaminated.The discoloration was reported to baxter and product return or exchange was requested, but refused.Baxter states the tubing is safe to use as discoloration is from the sterilization process.A letter from baxter was provided and attached to this report.However baxter has not provided additional details requested by (b)(6) leadership such as why only some sets are affected by the sterilization process, etc.(b)(6) has also noted there is now a disclaimer on some iv sets from baxter stating discolored sets are safe to use, but the disclaimer is not on all sets.2h7462 secondary tubing set known affected lots: r19i10108, r20g15033, r21k50079 and r21f16032.2,309 sets disposed.2r8538 primary tubing set known affected lots: dr21j30031, dr21i07062 and dr21l13024.588 cases quarantined at (b)(6) warehouse.2c8750 blood administration set: know affected lot; dr20i28040.52 sets disposed.2r8403 short primary set: no lot information available.158 sets disposed.Manufacturer response for iv tubing- short primary, (brand not provided) (per site reporter).Baxter declined offer to return affected product.Baxter states product is safe to use.Manufacturer response for iv tubing- blood administration set, (brand not provided) (per site reporter).Baxter declined offer to return affected product.Baxter states product is safe to use.Manufacturer response for iv tubing- primary set, (brand not provided) (per site reporter).Baxter declined offer to return affected product.Baxter states product is safe to use.Manufacturer response for iv tubing- secondary set, (brand not provided) (per site reporter).Baxter declined offer to return affected product.Baxter states product is safe to use.

Event Description

Since november of 2022 [redacted name] has been noting discolored iv tubing from baxter, this has occurred with 4 different types of tubing sets.The discoloration impacts clinical practice as it makes it difficult for the rn administering the iv solution/medication to see the fluid in the tubing, assess for air bubbles, particulate, etc.Infection control and clinical staff have expressed concern utilizing the discolored tubing while caring for the institute's high-risk patient population as they fear the tubing is contaminated.The discoloration was reported to baxter and product return or exchange was requested, but refused.Baxter states the tubing is safe to use as discoloration is from the sterilization process.A letter from baxter was provided and attached to this report.However baxter has not provided additional details requested by [redacted name] leadership such as why only some sets are affected by the sterilization process, etc.[redacted name] has also noted there is now a disclaimer on some iv sets from baxter stating discolored sets are safe to use, but the disclaimer is not on all sets.2h7462 secondary tubing set known affected lots: r19i10108, r20g15033, r21k50079, r21f16032, 2,309 sets disposed 2r8538 primary tubing set known affected lots: dr21j30031, dr21i07062, dr21l13024, 588 cases quarantined at [redacted name] 2c8750 blood administration set known affected lot; dr20i28040, 52 sets disposed 2r8403 short primary set no lot information available 158 sets disposed manufacturer response for iv tubing- short primary, (brand not provided) (per site reporter) baxter declined offer to return affected product.Baxter states product is safe to use.Manufacturer response for iv tubing- blood administration set, (brand not provided) (per site reporter) baxter declined offer to return affected product.Baxter states product is safe to use.Manufacturer response for iv tubing- primary set, (brand not provided) (per site reporter) baxter declined offer to return affected product.Baxter states product is safe to use.Manufacturer response for iv tubing- secondary set, (brand not provided) (per site reporter) baxter declined offer to return affected product.Baxter states product is safe to use.

• Brand Name: CLEARLINK/DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 17388366
• MDR Text Key: 319667692
• Report Number: 17388366
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2H7462
• Device Catalogue Number: 2H7462
• Device Lot Number: R19I10108,R20G15033,R21K50079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1