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

Catalog Number J2C1009

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a large volume infusor had a ¿pinhole at the center of the balloon¿ and there was a small amount of liquid inside the infusor housing.This issue was discovered during use at the hospital prior to use on a patient.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the device was manufactured from september 10, 2020 - september 11, 2020.H10: the evaluation of the actual device was completed.A visual inspection using the naked eye was performed which noted a small amount of fluid inside the housing because the bladder was ruptured in the form of a circular hole located at the lower part of the bladder.The ruptured bladder was examined for signs of abnormality that may have potentially caused the rupture problem.No signs of abnormality were found.The reported condition was verified.The cause of the condition was not determined; however the most probable cause is a manufacturing related 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
• MDR Report Key: 11405380
• MDR Text Key: 234477806
• Report Number: 1416980-2021-01009
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

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: 20J042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1