MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE FOLFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C4063K

Device Problem Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Four (4) single-use devices were received for evaluation.Visual and microscopic inspection did not identify any abnormalities that could have contributed to the reported condition.There was no evidence of damage or defect on the filters.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.

Event Description

This report summarizes 4 malfunction events.It was reported that the filters of four (4) large volume folfusors were damaged.The reporter stated that there was a small pinhole towards the end (bottom) of the filter.This was noted prior to patient use.No additional information is available.

• Brand Name: FOLFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; irvine CA
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9247622
• MDR Text Key: 172229346
• Report Number: 1416980-2019-05960
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412080161
• UDI-Public: (01)00085412080161
• Combination Product (y/n): N
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/28/2019

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?: No
• Device Operator: No Information
• Device Catalogue Number: 2C4063K
• Device Lot Number: 19E056
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/28/2019
• Type of Device Usage: N
• Patient Sequence Number: 1