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

Catalog Number 2C9961KP

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a multirate infusor lv (large volume) was broken.This was identified when the patient arrived for infuser withdrawal, after patient use.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from january 30, 2020 - january 31, 2020.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph was performed which did not identify a broken device.The reported condition of broken 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: 10617425
• MDR Text Key: 209557137
• Report Number: 1416980-2020-06141
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081502
• UDI-Public: (01)00085412081502
• Combination Product (y/n): Y
• PMA/PMN Number: K011317
• 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: 11/03/2020

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: Health Professional
• Device Catalogue Number: 2C9961KP
• Device Lot Number: 20A047
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1