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

Catalog Number 2C4711K

Device Problems Break (1069); Device Dislodged or Dislocated (2923); No Flow (2991)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter postal code:(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a small volume folfusor would not flow during patient infusion.It was further reported the balloon stem (stressmember) "appeared to be snapped and balloon alignment in the device seem to be off center".There was no damage to the packaging.The device contained fluorouracil 4800mg in sodium chloride 0.9%.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: device manufacture date: june 14, 2021 - june 15, 2021.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed on the photograph which displayed fluid inside the bladder.The photograph suggested a no flow condition may have occurred.The photograph also showed a crooked stressmember stem inside the housing of the device.The reported condition was verified.The cause of the condition could not be determined.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 ; 2242702068
• MDR Report Key: 12636066
• MDR Text Key: 276568077
• Report Number: 1416980-2021-06267
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412082172
• UDI-Public: (01)00085412082172
• Combination Product (y/n): Y
• Reporter Country Code: NZ
• 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: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4711K
• Device Lot Number: 21F036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: FLUOROURACIL; SODIUM CHLORIDE 0.9%