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

Catalog Number 2C1009K

Device Problem Break (1069)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tip of the syringe was broken and stuck inside the fill port of a large volume infusor.This occurred during filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d4 expiration date, h3, h4, h6, and h10: h4: the lot was manufactured between january 18, 2023 ¿ january 23, 2023.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection of the photo sample was performed, and a broken syringe tip (not a baxter product) was stuck inside the fill port.The reported condition was verified.The cause of the condition could not be determined.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: 18779498
• MDR Text Key: 336236449
• Report Number: 1416980-2024-00758
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412022529
• UDI-Public: (01)00085412022529
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

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: Other
• Device Catalogue Number: 2C1009K
• Device Lot Number: 23A015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/24/2024
• Supplement Dates FDA Received: 03/29/2024
• 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: NA.