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 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

Report source: foreign country: (b)(6).This report is related to the following reports: 3012307300-2020-00184, 3012307300-2020-00185, 3012307300-2020-00186, 3012307300-2020-00209, 3012307300-2020-00210, 3012307300-2020-00211, 3012307300-2020-00264.

Event Description

Information was received indicating that a difficult purge was experienced with 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 also 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: 9576140
• MDR Text Key: 176668528
• Report Number: 3012307300-2020-00265
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-7322-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/10/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 MO