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

Model Number	UNKNOWN
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.D4: model and catalog is unknown.H3: device not received by manufacturer.B3: date of event is unknown.
Event or Problem Description
It was reported that the batteries were under low tension and no longer charging.Per reporter when the pump was connected and started to the patient for chemotherapy treatment at the hospital, it caused the device to exhibit low battery alarm.Additionally, the battery had recently been recharged before use.No adverse patient effects were reported by the customer.
Additional Manufacturer Narrative
Date returned to mfg: 1/8/2024 one device was returned for evaluation.Visual inspection revealed the device in good condition.Event history log review was not applicable.Functional testing could not replicate the reported issue; the battery was able to be charged without issue.The root cause could not be determined.No further actions were taken.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.
Additional Manufacturer Narrative
While performing a review of the file it was determined that it was entered on the incorrect record type.Please disregard any reports associated with file mrn 3012307300-2023-12189.Please reference file mrn 3012307300-2024-07256 for all details pertinent to this event.

• Brand Name: CADD
• 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: 18383132
• Report Number: 3012307300-2023-12189
• Device Sequence Number: 7805808
• Product Code: MEA
• UDI-Device Identifier: 10610586031212
• UDI-Public: 10610586031212
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2024

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: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 01/24/2024; 03/05/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/20/2024; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CHEMOTHERAPY
• Patient Sex: Unknown