MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number EMC7109

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Date 12/16/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) university should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a control-a-flo extension set leaked during patient infusion with chemotherapy drug.After 20 minutes of infusion, 10ml of the chemotherapy drug pirarubicin was found on the quilt.The set was not tight resulting in the leak.The infusion was stopped and the set was replaced to resolve the event.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: the reported batch was produced on (b)(6)2023 h10: the actual device was not available; however, retained samples were evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional gravity and leak testing was performed; no leaks were observed.The reported condition was not verified on the retained samples.The samples were conforming per product specifications.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: I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - TUNISIA; route de chebbaou; 2021oued e; tunis ; TS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18548011
• MDR Text Key: 333346639
• Report Number: 1416980-2023-07097
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05413760192321
• UDI-Public: (01)05413760192321
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/20/2024

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: Health Professional
• Device Catalogue Number: EMC7109
• Device Lot Number: 23C24T372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 02/20/2024
• 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: PIRARUBICIN
• Patient Age: 52 YR
• Patient Sex: Male