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

Catalog Number 2C1008K

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a large volume infusor had a cracked administration tube.This issue was discovered prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured from september 3, 2019 - september 4, 2019.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was visually inspected and showed the tube set was detached from the stressmember which is located at the upper part of the device.The reported condition was verified during initial inspection and due to the nature of the returned sample, no additional testing could be performed.The cause of the condition was not determined; however the most probable cause of the condition is a manufacturing 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: 11325474
• MDR Text Key: 232334446
• Report Number: 1416980-2021-00611
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412022512
• UDI-Public: (01)00085412022512
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C1008K
• Device Lot Number: 19J021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1