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

Catalog Number 2C1702KP

Device Problem Material Deformation (2976)

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

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a small volume infusor was damaged.It was further reported, "a small visible red dot on the line" and "when the finger is rubbed over the line you can feel a slight indent".There was a concern "it might affect the flow rate".The set was filled with dextrose and 5-fluoruracil.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the device was manufactured from november 7, 2019 - november 8, 2019.H10: the actual sample was received for evaluation.Visual inspection was performed using the naked eye which revealed a reddish-brown particle, measuring 0.60 square mm.The particle was not in the fluid path due to being embedded in the material of the tubing line.The particle was subsequently identified to be polyvinyl chloride (pvc).Pvc is a raw material of the tubing line.The reported condition was verified.The cause of the condition was due to a supplier 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: 11395146
• MDR Text Key: 234213922
• Report Number: 1416980-2021-00950
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081441
• UDI-Public: (01)00085412081441
• Combination Product (y/n): Y
• PMA/PMN Number: K071222
• 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: 03/29/2021

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: 2C1702KP
• Device Lot Number: 19M009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 03/04/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1