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

Catalog Number 2C2118K

Device Problem Failure to Prime (1492)

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

Event Type  malfunction  

Manufacturer Narrative

This event occurred between (b)(6), 2021 and (b)(6), 2021.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of three (3) small volume intermates were not priming.The issue was identified after opening the clamp and no liquid was observed flowing.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufacture date: october 2, 2019 - october 3, 2019.H10: three (3) devices were received containing 80 ml of fluid in the bladders.Visual inspection using the naked eye did not identify any abnormalities that could have contributed to the reported condition.After the blue winged luer cap was removed and the slide clamp disengaged from the tubing line, evidence of continuous flow of fluid was observed coming out at the distal luer.A functional flow rate test was performed and the results were within the product specification range for all devices.The reported condition was not verified.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 ave.; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13176802
• MDR Text Key: 283316432
• Report Number: 1416980-2021-07712
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412487939
• UDI-Public: (01)00085412487939
• 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: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2118K
• Device Lot Number: 19K041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2022
• 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