MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD BLUE-STRIPED IV ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7059-24
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: facility name: (b)(6) hospital.H3: neither samples nor pictures were received for analysis.The device history record of reported possible lot numbers 6005507 was reviewed and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of the used samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.
Event or Problem Description
It was reported that the device over infused.Per reporter, the starting volume was 138ml, continuous infusion rate: 3ml/hour, reservoir volume: 10.1 ml on the pump settings and given: 138 ml.The amount of medication remaining in cassette did not match the reservoir volume displayed on the pump.They did not attempt to withdraw the remaining medication in the reservoir to confirm because the bag was empty.The air detector was off, and the upstream sensor was on.The length of infusion intended: 46 hours.Length of infusion (actual): 42.5hrs.They used a syringe as the line primed when the pump was not used.There was patient involvement, and no patient harm/adverse event reported.

• Brand Name: CADD BLUE-STRIPED IV ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20231109
• Report Number: 3012307300-2024-09297
• Device Sequence Number: 12879938
• Product Code: FPA
• UDI-Device Identifier: 10610586020421
• UDI-Public: (01)10610586020421(17)290418(10)6005507
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K990083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 21-7059-24
• Device Lot Number: 6005507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PUMP, CADD-LEGACY PLUS, MDL 6500, CE ENGLISH 1/EA; WALK MED LOT 20223502; WALK MED REFERENCE: (B)(4)
• Patient Sex: Unknown