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

Catalog Number ASKU

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter first name: (b)(6) e1: initial reporter facility name: (b)(6) e1: initial reporter city: (b)(6) e1: initial reporter phone no.Télécopieur : (b)(6) should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a user error during preparation of an unspecified elastomeric device used for fluorouracil chemotherapy.The user error involved using an lv5 infusor instead of a lv10 infusor which resulted in the patient receiving chemotherapy at the wrong rate ("50% of the intended chemotherapy dose missing").There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

B5: clarification was received from the customer stating: ¿there is no complaint related to the quality of the product delivered by baxter¿.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Upon further review, the baxter device is no longer considered a suspect product in this event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• 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: 17444298
• MDR Text Key: 320240615
• Report Number: 1416980-2023-03887
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• 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: 08/31/2023

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 08/05/2023
• Supplement Dates FDA Received: 08/31/2023
• 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: DEXTROSE 5%; FLUOROURACIL