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

Catalog Number D2C4063K

Device Problems Crack (1135); Material Discolored (1170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This event occurred during the unspecified date and month of year 2021.The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that ¿hairline cracking¿ was observed on the fill ports of two (2) folfusors lv (large volume).This issue was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: two (2) actual devices were received for evaluation containing fluid in the bladder.Visual inspection was performed which observed vertical cracks located on the fill port.The reported condition was verified for both samples.The cause of the condition could not be determined, however, the probable cause of the cracks may likely be due to the use of excess alcohol solution to clean the fill port either prior, during or after the filling step.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: FOLFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11477645
• MDR Text Key: 239735115
• Report Number: 1416980-2021-01301
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412474335
• UDI-Public: (01)00085412474335
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: D2C4063K
• Device Lot Number: 19K034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Date Manufacturer Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1