MAUDE Adverse Event Report: SMITHS MEDICAL CADD HIGH VOLUME ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

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.

• Brand Name: CADD HIGH VOLUME ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 7078869
• MDR Text Key: 93762000
• Report Number: MW5073699
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/15/2022
• Device Model Number: 21-7355-24
• Device Catalogue Number: 21-7355-24
• Device Lot Number: 27X192
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 71