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

Catalog Number 2C2009K

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that a large volume infusor leaked inside a bag.This was observed during device preparation for delivery to the clean room.There was no patient involvement.No additional information is available.

Manufacturer Narrative

E1: initial reporter phone no.(b)(6).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device contained 100ml of dextrose 5% in water.The lot was manufactured between august 10, 2023 - august 14, 2023.The actual device was received for evaluation.Visual inspection was performed which identified fluid inside a bag that contained the unit.The cause of leak inside the bag was found to be an untightened winged luer cap.Signs of surface roughness were not observed inside the cap when inspected under the microscope.A functional leak test was performed by filling the unit with green color water and the cap was hand tightened; the device was monitored till the next day and no signs of leak were observed.The device was determined to be conforming product during functional testing.The reported condition was verified during inspection; however, not verified during functional testing.The cause of the condition could not be determined; however, the probable cause is use-related due to not securely tightening the winged luer cap.The product label (ifu, instructions for use) indicates to ensure the cap is securely connected after filling and priming.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: INFUSOR
• 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: 18784714
• MDR Text Key: 336291575
• Report Number: 1416980-2024-00775
• Device Sequence Number: 1
• Product Code: MEB
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C2009K
• Device Lot Number: 23H028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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