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

Model Number	2160
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: no product returned, but photos were provided.Visual inspection of photos provided was done.Batteries looked to be in poor condition with visible cracks seen on some of the batteries in the pictures.The cause of the cracks was probably due to physical damage.No further action was taken.
Event or Problem Description
It was reported that the rechargeable battery pack housing is cracked or damaged.The results of the investigation found that the batteries looked to be in poor condition with visible cracks seen on some of the batteries in the pictures.There was no patient involvement, and no patient harm/adverse event reported.

• Brand Name: AMBULATORY PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21610032
• Report Number: 3012307300-2025-02914
• Device Sequence Number: 7756353
• Product Code: MEA
• UDI-Device Identifier: 10610586031212
• UDI-Public: (01)10610586031212
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 03/14/2025

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: 2160
• Device Catalogue Number: 21-2160-51
• 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: 02/15/2025
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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