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

Catalog Number 2C2113K

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a ce intermate lv (large volume) did not infuse at all during a patient infusion.The device was filled with 1g methylprednisolone (solumedrol, non-baxter) and 250ml "g5%" (glucose, non-baxter).There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: device manufactured between october 1, 2019 to october 2, 2019.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERMATE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11041162
• MDR Text Key: 222632112
• Report Number: 1416980-2020-07910
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412487977
• UDI-Public: (01)00085412487977
• 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: 01/19/2021

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: Other
• Device Catalogue Number: 2C2113K
• Device Lot Number: 19K011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: G5%; SOLUMEDROL