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

Catalog Number J2C1009

Device Problem Break (1069)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the fill port of a large volume infusor was damaged.The damage was discovered while filling the device with fluorouracil.There was no patient involvement.No additional information is available.

Manufacturer Narrative

B5: the set was filled with glucose and at the time of the leak fluorouracil was being added.H4: device manufacture date: the device was manufactured between 30mar2023 and 31mar2023.H10: the device was received for evaluation containing fluid in the bladder.During visual inspection the cracks were observed on the fill port.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause may be due to the customer inadvertently applying excess force onto the fill port during fill which consequently caused cracks to the fill port.During manufacturing, the device was 100% visually inspected by manufacturing assemblers for damage, and therefore, cracks on the fill port would have been detected and rejected by manufacturing assemblers.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: 18876352
• MDR Text Key: 337342624
• Report Number: 1416980-2024-01049
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04987456503919
• UDI-Public: (01)04987456503919
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/16/2024

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: J2C1009
• Device Lot Number: 23C010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 05/16/2024
• 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