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

Catalog Number	21-7355-24
Medical Device Problem Codes	Failure to Deliver (2338); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Dehydration (1807); Diarrhea (1811)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7205600
• Report Number: 3012307300-2018-00139
• Device Sequence Number: 853946
• Product Code: FPA
• UDI-Device Identifier: 10610586027376
• UDI-Public: 10610586027376
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/19/2018

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Initial Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5073699
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NORMAL SALINE 2L BOLUS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Weight: 70