MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. RECHARGEABLE BATTERY PACK; PUMP, INFUSION, PCA

Model Number	21-2160-51
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: equipment & return technician.
Event or Problem Description
Information was received indicating that a smiths medical rechargeable battery pack would not get fully charged; it only accepted 75%.The issue occurred during a procedure and there was no reported impact on patient outcome.
Additional Manufacturer Narrative
Returned device was received in good physical condition.During the evaluation of the device, the issue was not confirmed.The battery back connected to a charged and using the battery with a different pump, the pump indicated 100 percent charge.No fault found with the returned product.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: RECHARGEABLE BATTERY PACK
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9960085
• Report Number: 3012307300-2020-03007
• Device Sequence Number: 11601614
• Product Code: MEA
• UDI-Device Identifier: 10610586031212
• UDI-Public: 10610586031212
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: Other
• Device Model Number: 21-2160-51
• Device Catalogue Number: 21-2160-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CADD SOLIS VIP PUMP; CADD SOLIS VIP PUMP