MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-LEGACY PCA AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA

Model Number	6300
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: event date is unknown; it is known that the event happened at the beginning of october.E1: initial reporters address 1; (b)(6).E1: initial reporers address 2; (b)(6).One device was received for analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.The customer reported event was duplicated.Visual test performed and found damage to the rear housing.Functional testing performed and found the air detector is defective.The rear housing and air detector was replaced.
Event or Problem Description
It was reported that the device air problem was detected.The problem was detected when the tubing was placed before use on patient.

• Brand Name: CADD-LEGACY PCA AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION, PCA
• 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: 20918220
• Report Number: 3012307300-2024-14835
• Device Sequence Number: 5294420
• Product Code: MEA
• UDI-Device Identifier: 10610586019357
• UDI-Public: (01)10610586019357(11)060419
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982839
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

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 Model Number: 6300
• Device Catalogue Number: 21-6300-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2006
• 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