MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7092-24

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

H3: device not received by manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

It was reported that when using the cassette extender with multiple pumps, the pump would exhibit an occlusion alarm.It was stated that the pumps worked with other cassettes without issue.It is unknown if there was patient involvement, no adverse patient effects were reported.

Manufacturer Narrative

Device evaluation: 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.B5: it was reported that the pump would go into occlusion alarm when using the cassette extender.The cassette extender was changed three times (same lot) but the same issue occurred.Only one pump was used by the facility for this event, and it had been used successfully with cassette extenders of other lot numbers.It was clarified that there was no issue with the pump.

• Brand Name: CADD ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18432150
• MDR Text Key: 331892407
• Report Number: 9617604-2024-00003
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586024177
• UDI-Public: 10610586024177
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K000942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7092-24
• Device Lot Number: 4342643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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: CADD INFUSION PUMP