MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. RESERVOIR, CASSETTE, 250ML, FS 12/BX; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7308-24

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Pyrosis/Heartburn (1883)

Event Date 11/17/2023

Event Type  malfunction  

Event Description

It was reported that the device infused faster than the 46-hour programmed infusion.The infusion ended five to six hours early.Per reporter the patient experienced a stomachache, no other adverse patient effects were reported by the customer.The device settings were reviewed, air in line was noted.

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.H3: device has not been returned to manufacturer.

Manufacturer Narrative

No product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: RESERVOIR, CASSETTE, 250ML, FS 12/BX
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana CA ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane south; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18347409
• MDR Text Key: 331073613
• Report Number: 9617604-2023-00019
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586032370
• UDI-Public: 10610586032370
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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: Lay User/Patient
• Device Catalogue Number: 21-7308-24
• Device Lot Number: 4381268
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• 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: 5-FLUOROURACIL.; CADD EXTENSION SET.; CADD PUMP.