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

Catalog Number 2C2122K

Device Problems Material Twisted/Bent (2981); No Flow (2991)

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

Event Date 11/16/2022

Event Type  malfunction  

Event Description

It was reported that the line attached was kinked and bent and could not be corrected resulting in a no flow of unspecified antibiotics through the line of a large volume intermate.The issue was identified during setup/preparation prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H4: device manufacture date: march 7, 2022 - march 8, 2022.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition; there was no evidence of kink or bend observed on the tubing line from the photo.The tubing line appeared to be in normal condition, however, it was noted that the blue slide clamp was closed on the tubing line which would result in a no flow of fluid.The reported condition was verified.The cause of the condition could not be determined; however, the reported condition may potentially be due to a use error as during product use, the blue slide clamp must be opened to allow flow of fluid through the tubing line.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: 15969965
• MDR Text Key: 307887155
• Report Number: 1416980-2022-06830
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412487892
• UDI-Public: (01)00085412487892
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2122K
• Device Lot Number: 22C013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2023
• 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