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

Catalog Number J2C1711

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2020

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 small volume infusor leaked from the bladder or tubing (not further clarified) during patient infusion.There was damage on the surface of the housing and coil cap.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H4: the lot was manufactured from march 24, 2020 - march 25, 2020.H10: the device was received for evaluation with no fluid in the bladder.Visual inspection was performed using the naked eye which observed dents on the housing and the pink coil cap.Additionally, a scrape was observed on the tubing line.Functional testing was performed by filling the device with green colored water.During fill, a leak was observed from the scrape on the tubing line only.There was no leak observed from any other part of the device.The reported condition was verified.The cause of the condition was due to user induced damage.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: 10701318
• MDR Text Key: 212108201
• Report Number: 1416980-2020-06489
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

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: J2C1711
• Device Lot Number: 20C010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1