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

Model Number 21-7346-24

Device Problems Device Alarm System (1012); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the device was not returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that a patient realized that his tubing was still clear with saline from priming, and the red adriamycin had never entered the tubing even though the pump displayed that it was running.The pump had not alarmed.The pump was switched.The tubing filled with the red medication.The next morning, the bag still appeared very full.It appeared that the patient had not received any medication over the last two days.The pump still displayed running and the amount it said was left would have been appropriate if it was actually running, but the bag clearly had about 1000 cc left.There was no patient injury reported.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updates not required.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• Brand Name: CADD HIGH VOLUME ADMINISTRATION SET
• 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: 15015245
• MDR Text Key: 304174586
• Report Number: 3012307300-2022-13337
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1