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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET WITH BAG SPIKE; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET WITH BAG SPIKE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 4309467
Device Problems Device Alarm System (1012); Nonstandard Device (1420); Infusion or Flow Problem (2964)
Patient Problem Insufficient Information (4580)
Event Date 11/21/2022
Event Type  malfunction  
Event Description
Patient was prescribed fluorouracil 3820mg over 46 hours via cadd pump to start on (b)(6) 2022.Bag was hung and patient was started on the infusion.When the patient returned on (b)(6) 2022 to have the bag disconnected, the nurse noticed that the bag appeared to still have significant volume left.The patient reported the pump did not alarm.Pump was retained to send to the vendor for diagnostics when the recall notice for admin sets was received from smith medical.The pharmacy does not record lot numbers for supplies used, but the pharmacy did have stock of affected lot numbers including a partially used case of an affected lot.
 
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Brand Name
CADD ADMINISTRATION SET WITH BAG SPIKE
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key16052925
MDR Text Key306337490
Report NumberMW5114030
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/22/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number4309467
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/23/2022
Patient Sequence Number1
Treatment
OXALIPLATIN 170MG; CETUXIMAB 1000MG; FLUOROURACIL ; LEUCOVORIN 800MG
Patient Age60 YR
Patient SexPrefer Not To Disclose
Patient Weight82 KG
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