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

Catalog Number 2C1009K

Device Problem Material Rupture (1546)

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

Event Date 01/15/2024

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 bladder of a large volume infusor ruptured.This occurred during setup prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured between january 27, 2023 ¿ january 28, 2023.H10: the device was received for evaluation.A visual inspection was performed, and it was noted that there was fluid contained inside the housing.Further inspection revealed the cause of fluid inside the housing was due to missing film-wrap.No evidence of rupture was observed from the bladder.The film-wrap is located at the upper area of the bladder.The film-wrap fastens the bladder to the stressmember.When the film-wrap is missing, the bladder would not inflate during fill and the fluid would leak inside the housing.The reported condition was verified.The cause of the reported condition was a manufacturing issue.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: 18669216
• MDR Text Key: 334911144
• Report Number: 1416980-2024-00431
• Device Sequence Number: 1
• Product Code: MEB
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C1009K
• Device Lot Number: 23A031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/04/2024
• 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