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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7346-24
Device Problems Insufficient Flow or Under Infusion (2182); Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2022
Event Type  malfunction  
Event Description
It was reported that the patient connected to cadd pump via picc line.Patient returned the second day to report full bag of medication had not infused.Cadd pump indicated 106ml to be infused for another 5 hours according to settings, however bag remained full.Cadd pump switched and same bag and tubing connected.Patient sent home and instructed to return next morning.Patient returned with bag still full of medication.Cadd pump indicated 108mls more to be infused for another 5 hours.A new epoch(etoposide, doxorubicin, vincristine) bag and tubing attached and same cadd pump used.Patient sent home and instructed to return to center at 1600c-hrs.Patient returned and 120mls of drug infused.No patient injury was reported.
 
Manufacturer Narrative
Device evaluation: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.
 
Event Description
Additional information stated that the pump did not alarm at the time of all the under infusion events.
 
Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.B5: updated.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).The device was returned for investigation.Visual inspection and functional test were performed.Visual inspection found no obstructions nor other workmanship defects in none of the joins of the products.The reported problem was not duplicated.No discrepancies were detected on the sample.Sample was fully priming and connected without difficulty.The pump was set running and no alarms were activated and no occlusions detected, the test successfully passed, thus, the failure mode reported was not confirmed.No root cause was determined as the complaint was not confirmed.No corrective actions were taken as the complaint was not confirmed.No problems or issues were identified during this device history record review., corrected data: correction: d4: catalog number: 21-7346-24.Correction: d4: model number: blank.Correction: h5: labeled for single use: yes.
 
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Brand Name
CADD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
NULL
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key14362436
MDR Text Key291629914
Report Number3012307300-2022-08555
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517161953
UDI-Public15019517161953
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-7346-24
Device Catalogue Number21-7346-24
Device Lot Number4235006
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient SexMale
Patient Weight75 KG
Patient RaceWhite
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