• 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 CADD HIGH VOLUME ADMINISTRATION SET 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 CADD HIGH VOLUME ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7355-24
Device Problems Failure to Prime (1492); Failure to Infuse (2340)
Patient Problem Dehydration (1807)
Event Date 11/28/2017
Event Type  Injury  
Event Description
The evening of (b)(6) 2017 prepared and hooked up my iv normal saline fluids via cadd from pump and the smiths medical - cadd high volume admin set, ref # (b)(4) in lot # 27x192 expiring 06/15/2022 and started the pump administering as normal over a 12 hr cycle. The next morning, i did not feel well in state of dehydration from what i thought was just diarrhea the evening before. Upon scheduled change of the iv bag and tubing, i noticed that the bag, originally prepared with 1700mls for a 1500mls infusion with overfill, still contained what appeared to be just over 1600mls of 0. 9% normal saline yet the pump was indicating that the bag should have been nearly empty and was pumping as normal. I disconnected the tubing set from my port line to find the pump was pumping but the fluid was not advancing in the line. So all night while the pump was sounded and appeared to be pumping, in reality no fluid was being administered. I did have problems that previous evening getting the normal saline to initially prime the line but it did prime after a few minutes, so i had not thought much of it. The tpn being administered through the same port, same extension set but a different set of tubing and different pump were normal and had pumped as they should have. With the combined diarrhea, loss of fluids, and the iv normal saline not having administered properly, i quickly identified that i was dehydrated and needed to get my fluid volume back up. Fortunately, i still have enough dexterity and cognition to identify the issue, prepare and administer a bolus back of normal saline. On (b)(6) 2017, i connected a new set of tubing to a new bag of normal saline to the same cadd prizm pump that had the administration problem the night before and this time everything worked properly. Based on all the factors, years of experience and the benefit of hindsight, i concluded that the tubing set had some type of problem that hindered proper flow down the line and prevented administration. Unfortunately, i had discarded the set of tubing while dehydrated into the rubbish and no longer have it.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCADD HIGH VOLUME ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL
MDR Report Key7078869
MDR Text Key93762000
Report NumberMW5073699
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7355-24
Device Catalogue Number21-7355-24
Device Lot Number27X192
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/01/2017 Patient Sequence Number: 1
-
-