MAUDE Adverse Event Report: ICU MEDICAL, INC RECHARGEABLE BATTERY PACK; PUMP, INFUSION, PCA

Catalog Number	21-2160-51
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.The device has not been returned to the manufacturer.
Event or Problem Description
It was reported that the pump returned from clinical use and connected to ac cable to charge.Pump switched on, on-screen alarm ¿battery depleted pump will not run¿ battery indicator at 0 percent.Battery removed from pump and inserted into three different proven functioning devices, same alarm on each occasion.On inspection battery indicator was illuminating green.Battery pack inserted into four different functioning pumps, all failed with ¿battery depleted pump will not run¿ battery indicator at 0 percent.Event occurred at hospital during pre-test.
Additional Manufacturer Narrative
The suspected device was returned for evaluation.The device was visually inspected and there were no damages.A visual inspection was performed and the reported issue was not confirmed.The cause of the reported issue was unknown.

• Brand Name: RECHARGEABLE BATTERY PACK
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL, INC; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23636428
• Report Number: 3012307300-2025-12818
• Device Sequence Number: 9290365
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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 Catalogue Number: 21-2160-51
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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