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

Catalog Number 2C2120K

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 10/06/2023

Event Type  malfunction  

Event Description

It was reported that two (2) large volume intermates leaked into the overpouch.The blue end cap had come off the tubing and most of the fluid had drained out of the elastomeric sleeve in the bottles.The devices had been filled with 0.9% sodium chloride.This was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from november 04 - november 05, 2022.The actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was reviewed and showed fluid inside a bag that contained the two devices which suggested a leak occurred.The reported condition was verified.The cause of leak could not be determined, but was most likely due to detached distal luer lock where the blue winged luer cap was attached.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
• 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: 18041224
• MDR Text Key: 326988452
• Report Number: 1416980-2023-05570
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412487922
• UDI-Public: (01)00085412487922
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2120K
• Device Lot Number: 22M002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: NA.