MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; ACCESSORIES, PUMP, INFUSION

Catalog Number	21-2131-01
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was received for evaluation.Functional testing was unable to duplicate the reported issue when connected to a known good operating pump; however, upon further investigation, failure often occurs with newly built pumps.The root cause was unable to be determined.
Event or Problem Description
It was reported that the device alarmed for an intermittent wireless module connection error when connected to ac power.The product fault occurred upon opening.It was an out of box failure.There was no patient involvement.

• Brand Name: CADD
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20423413
• Report Number: 3012307300-2024-10876
• Device Sequence Number: 8420430
• Product Code: MRZ
• UDI-Device Identifier: 15019517173864
• UDI-Public: (01)15019517173864(17)240905(10)19009199
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/10/2024

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 Expiration Date: 09/05/2024
• Device Catalogue Number: 21-2131-01
• Device Lot Number: 19009199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown