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

Catalog Number 2C2008K

Device Problem Backflow (1064)

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

Event Date 07/12/2021

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 there was backflow with two (2) large volume infusors during filing with normal saline.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: one (1) actual device was received for evaluation containing fluid in the bladder.The other sample was not received and therefore, could not be evaluated.Visual inspection revealed a leak/backflow at the fill port when the fill port cap was removed.The cause of the leak/backflow was due to a particle lodged under the device checkband.The particle was subsequently identified to be acrylic material via fourier transform infrared spectroscopy (ftir) test.Acrylic is the material of the device stressmember.The reported condition of backflow was verified.The cause of the particle under the checkband could not be determined; however, the most probable cause was small shaving from the stressmember created during manufacturing which get stuck under the checkband.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: 12294025
• MDR Text Key: 265591206
• Report Number: 1416980-2021-04871
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412579382
• UDI-Public: (01)00085412579382
• 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: 09/08/2021

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: 2C2008K
• Device Lot Number: 21B010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 09/06/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1