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

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.

• 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 Key: 14362436
• MDR Text Key: 291629914
• Report Number: 3012307300-2022-08555
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7346-24
• Device Catalogue Number: 21-7346-24
• Device Lot Number: 4235006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White