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

Catalog Number D2C4711K

Device Problem Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Event Description

It was reported that the balloon (bladder) of a small volume folfusor was not properly anchored in the container; it wobbles very strongly and rotates when the stopper moves.This issue was discovered during filling.The device was filled with 0.9% sodium chloride.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Initial reporter address: (b)(6).Initial reporter city: (b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: lot manufacture date: may 24, 2021 - may 25, 2021.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional test was performed by manually inserting a syringe into the fill port of the folfusor device in preparation for filling.During insertion of the syringe, the stressmeber flange slightly wiggled back and forth.However, the device was able to be filled to the nominal volume without extreme difficulty.Therefore, this condition is cosmetic and does not impact the function of the product.The reported condition was verified.The cause of this cosmetic condition may be related to an assembly issue during manufacturing.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
• 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: 15970985
• MDR Text Key: 307568312
• Report Number: 1416980-2022-06843
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412474311
• UDI-Public: (01)00085412474311
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: D2C4711K
• Device Lot Number: 21E032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1