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

Catalog Number 2C1009K

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a large volume infusor was leaking from the filling port.This occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The lot was manufactured from october 12, 2018 - october 16, 2018.H10: the device was received for evaluation.Visual inspection revealed leak/backflow at the fill port after the fill port cap was removed from the port.Additional examination on the device revealed the cause of leak/backflow at the fill port was due to a glass fragment lodged under the device checkband.The reported condition was verified.The cause of the glass fragment could not be determined, however the most probable cause is due to user filling techniques related to glass ampule usage.No manufacturing process step would allow glass fragments to be introduced near or adjacent to the fill port.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: 9532444
• MDR Text Key: 173204668
• Report Number: 1416980-2019-07252
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412022529
• UDI-Public: (01)00085412022529
• 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: 01/29/2020

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 Expiration Date: 10/01/2021
• Device Catalogue Number: 2C1009K
• Device Lot Number: 18K001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1