MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7322-24

Device Problems Insufficient Flow or Under Infusion (2182); Priming Problem (4040)

Patient Problems Weakness (2145); Lethargy (2560)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Report source: foreign country: (b)(6).This report is related to the following reports: 3012307300-2020-00185, 3012307300-2020-00186, 3012307300-2020-00209, 3012307300-2020-00210, 3012307300-2020-00211, 3012307300-2020-00264, 3012307300-2020-00265.

Event Description

Information was received indicating that an abnormal purge was experienced using a smiths medical cadd administration set used for infusion of parenteral nutrition.The treatment was reported as "pediatric npad/550ml/12h 7d/7." it was reported that the purge was unsuccessful using one pump and that after two tests another pump was used to finish the purge and the infusion.It was reported that the patient experienced severe asthenia and that subsequently it was required to change the pump and administration sets.No additional adverse effects were reported.

• Brand Name: CADD ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. .; ave calidad no. 4,; parque industrialinternacional; tijuana, 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 9576124
• MDR Text Key: 176878990
• Report Number: 3012307300-2020-00184
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029646
• UDI-Public: 10610586029646
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-7322-24
• Device Lot Number: 3834182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 MO