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

Catalog Number 21-7322-24

Device Problems Bent (1059); Insufficient Flow or Under Infusion (2182); Physical Resistance (2578)

Patient Problems Complaint, Ill-Defined (2331); Underdose (2542)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

Voluntary medwatch form #: mw5066840.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a cadd® administration set had an issue of underinfusion and air in the line as well as the filter.The incident may have been related to bending in the add-on filter and/or antisiphon valve or the increased resistance due to the add-ons.The bending in the add-ons was corrected.The underinfusion was between 15% and 56%, and the patient was compromised and needed additional care.The patient required higher levels of monitoring.It was unclear what the impact to the patient was.See mfr: 3012307300-2017-00557, 3012307300-2017-00558, and 3012307300-2017-00559.

• Brand Name: CADD® ADMINISTRATION SETS
• 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 MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6339227
• MDR Text Key: 67694856
• Report Number: 3012307300-2017-00557
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029646
• UDI-Public: 10610586029646
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7322-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• 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): Hospitalization; Life Threatening; Other; Required Intervention