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

Catalog Number 2C4705K

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

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that a small volume folfusor leaked from a loose blue winged luer cap.After filling and delivering the folfusor, it was discovered that the blue winged luer cap was disconnected from the distal luer connector.This occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: the lot was manufactured between august 16-17, 2023.H10: the actual device was received for evaluation.A visual inspection was performed and fluid was observed inside a bag that contained the device.When the device was removed from the bag, the cause of leak was found to be a separated winged luer cap.Microscopic inspection observed no signs of surface roughness inside the cap.A functional leak test was performed by filling the device with green color water to the nominal volume.After fill and prime, the cap was hand tightened and monitored until the next day; no signs of leak were observed.The reported condition was verified during visual inspection; however, not verified during functional testing.The cause of the condition could not be determined; however, a probable cause is related to user error.The product label (ifu, instructions for use) indicates to securely connect the cap after filling and priming.The device was found to be conforming product during functional testing.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: FOLFUSOR
• 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: 18704683
• MDR Text Key: 335441818
• Report Number: 1416980-2024-00557
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081588
• UDI-Public: (01)00085412081588
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4705K
• Device Lot Number: 23H010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2024
• 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