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

Catalog Number D2C4711K

Device Problem No Flow (2991)

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

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a small volume folfusor had no flow.This was discovered during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction b5: change quantity to (2) two units (previously reported as one unit.H4: the lot was manufactured on may 4, 2023 ¿ may 5, 2023.H10: two devices were received for evaluation.The units contained fluid in their bladder.A visual inspection with the naked eye was performed on the devices, which showed no evidence of fluid coming out at the distal end of the flow restrictors.A microscopic examination on the flow restrictors revealed the cause of the flow problem was due to a series of micro-air bubbles blocking the fluid path inside the lumen of the capillary glass.The capillary glass is located inside the flow restrictor housing.The reported condition was verified.The cause of the condition was determined to be user related due to the air bubbles inside the lumen of the capillary glass, which is caused by an improper filling technique during product use (filling step).The product label, instructions for use, details the proper filling technique to avoid this type occurrence.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: 17897561
• MDR Text Key: 325252565
• Report Number: 1416980-2023-05109
• 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: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: D2C4711K
• Device Lot Number: 23E026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NI.