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

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 10/28/2023

Event Type  malfunction  

Event Description

It was reported that the administration tubing of an unspecified elastomeric device had separated from the pump which resulted in a medication leak.This issue was further described as, ¿that the line fell out already and was not attached to the bottle, hence all contents leaked out¿.This occurred during set up prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction made to b5: it was reported that a small volume intermate leaked (previously submitted as an unspecified elastomeric device).Correction made to d1: brand name: intermate (previously submitted as ni).Correction made to d2a: common device name: pump, infusion (previously submitted as pump, infusion, elastomeric).Correction made to d2b: classification code: frn (previously submitted as meb).Correction made to d4: catalogue #: 2c2111k (previously submitted as ni).Correction made to d4: lot #: 23f024 (previously submitted as ni).Correction made to d4: unique identifier (udi) #: (b)(4) (previously submitted as ni).H4: the lot was manufactured between june 12, 2023 ¿ june 13, 2023.H10: the device was received for evaluation.Visual inspection was performed and a broken tubing line at junction of the stressmember.A portion of the broken tubing still remained inside the stressmember.The reported condition was verified.Microscopic inspection on the broken tubing suggested the probable cause of broken tubing that resulted in leak may be use-related.The tubing line may have been pulled with excess force during use which caused the tubing line to break off at the junction of the stressmember located at the upper area of the device.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: 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: 18212115
• MDR Text Key: 329042237
• Report Number: 1416980-2023-06162
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/19/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 12/04/2023
• Supplement Dates FDA Received: 12/19/2023
• 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
• Treatment: NA.