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

Catalog Number 21-7346-24

Device Problems Device Alarm System (1012); Obstruction of Flow (2423); Air/Gas in Device (4062)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

It was reported the pump alarmed occlusion.Options given were silence and help.Silenced pump, clicked on help.Device said to insert spike fully into bag, pushed both spikes in they didn?t move.They appeared to have been pushed in fully.Checked patient port clamp and admin set clamp, both open.Occlusion did not clear.Unlocked admin set from pump, removed and pressed and held green flow stop button, aligned tubing and ran my thumb over the top of it and reinserted onto pump.Closed lock and got notification that occlusion was cleared.Nurses reverified delivery settings started pump.Waited until.1 was administered without an alarm and patient went home.No patient injury reported.

Manufacturer Narrative

Other text: 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.

Manufacturer Narrative

Other text: one sample was received for evaluation.Visual inspection revealed no damage or other defects.Functional testing was performed but the reported issue could not be replicated.No root cause could be determined as no device problem was found.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No action was taken.Email address: regulatory.Responses@icumed.Com.

• Brand Name: CADD 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17782130
• MDR Text Key: 323849533
• Report Number: 3012307300-2023-09131
• Device Sequence Number: 1
• Product Code: FPA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

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 Catalogue Number: 21-7346-24
• Device Lot Number: 4339154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1