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

Catalog Number 2C4702K

Device Problem Material Deformation (2976)

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

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hopitaux.The devices have 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 the plastic of four (4) small volume folfusors was curved inward in places.This was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured on april 11, 2022, to april 13, 2022.Four actual devices were received for evaluation.A visual inspection with the naked eye was performed which noted that the housing was malformed and caused the yellow color coil cap to separate from the housing.When the housing is malformed, particularly at the neck area of the housing, the coil cap no longer fits the housing and this issue would cause it to separate from the housing.The reported condition was verified.The cause of the condition was determined to be due to extreme heat temperature during shipping.A nonconformance has been opened to address this issue.Malformed/deformed housing would be apparent at the time of preparation and filling of the device and render the device unusable.As this is an obvious issue that would be noted during preparation, the device would be discarded and not sent to the patient for use.The reported issue would lead to delay in therapy as the customer has the option to replace with new supplies.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: 17396986
• MDR Text Key: 320668989
• Report Number: 1416980-2023-03781
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412080154
• UDI-Public: (01)00085412080154
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/31/2023

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: 2C4702K
• Device Lot Number: 22D016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 08/27/2023
• Supplement Dates FDA Received: 08/31/2023
• 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