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

Catalog Number 21-7355-24

Device Problems Failure to Deliver (2338); Infusion or Flow Problem (2964)

Patient Problems Dehydration (1807); Diarrhea (1811)

Event Date 11/28/2017

Event Type  Injury  

Event Description

Information was received indicating that a smiths medical cadd® high-volume administration set was difficult to prime for a scheduled infusion of 1500 cc of normal saline (ns).The patient found the next day that none of the normal saline was administered overnight.The tubing was disconnected from the port and the pump was noted to be pumping as normal but that the fluid was not advancing through the line.Total parenteral nutrition (tpn) was being administered at same time with no problems reported.The patient reported feeling "dehydrated" with diarrhea the prior day.No adverse effects were reported but a two liter bolus of normal saline was ordered and infused.

• Brand Name: CADD® HIGH-VOLUME 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 MANUFACTURING; s.a. de c.v.; a d no.4 parque industrial int; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7205600
• MDR Text Key: 97738042
• Report Number: 3012307300-2018-00139
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027376
• UDI-Public: 10610586027376
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/15/2022
• Device Catalogue Number: 21-7355-24
• Device Lot Number: 27X192
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: MW5073699
• Patient Sequence Number: 1
• Treatment: NORMAL SALINE 2L BOLUS
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 70