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

Catalog Number J2C1009

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tubing of a large volume infusor had black particulate matter (pm).This occurred during filling at the hospital.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The lot was manufactured from may 17, 2019 - may 21, 2019.H10: the actual device was received for evaluation.A visual inspection was performed and found a dark brown particle located inside the tubing line.The particle was not moving inside the tubing line.The particle was subsequently identified to be polyvinyl chloride (pvc) material via ftir spectroscopy testing.Pvc is the raw material of the device tubing line.The reported condition was not verified.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: 9532765
• MDR Text Key: 173199785
• Report Number: 1416980-2019-07268
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• 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: 02/05/2020

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: J2C1009
• Device Lot Number: 19E051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1