MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERMATE; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C2123K

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It was reported an unspecified particulate was observed in the tubing of an xlv intermate during preparation prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: d4, d9, h3, h4, h6, h10.H4: the lot was manufactured august 16, 2023 and august 17, 2023.H10: the actual device was received for evaluation.A visual inspection observed a black particle, embedded in the material of the tubing line.The particle was molded within the material of the tubing line and was not in the fluid path.The particle was identified to be a mixture of polyvinyl chloride (pvc) and phthalate material via a fourier transform infrared spectroscopy (ftir) test.Pvc is the material of the device tubing line.The reported condition was verified.The cause of the condition was manufacturing related.However, since the particle was not in the fluid path, it is unlikely to cause harm.This issue does not impact the sterile pathway and does not impact the product delivered to the patient.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: INTERMATE
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18956696
• MDR Text Key: 338473411
• Report Number: 1416980-2024-01271
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412488172
• UDI-Public: (01)00085412488172
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• 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: 04/23/2024

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: 2C2123K
• Device Lot Number: 23H030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/03/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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