• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. CADD® HIGH-VOLUME ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCADD® HIGH-VOLUME ADMINISTRATION SETS
Type of DeviceSET, 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 Key7205600
MDR Text Key97738042
Report Number3012307300-2018-00139
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
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 Received01/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number21-7355-24
Device Lot Number27X192
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberMW5073699

Patient Treatment Data
Date Received: 01/19/2018 Patient Sequence Number: 1
Treatment
NORMAL SALINE 2L BOLUS
-
-