MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC CADD ACCESSORIES BATTERY; ACCESSORIES, PUMP, INFUSION

Model Number	BATTERY PACK, RECHARGEABLE, LITHIUM ION, 3.7V, 1400
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis is done by supplier, which is ultralife corp.Sqe: (b)(6).
Event or Problem Description
Information received a smiths medical cadd assessories battery will only charge and accept 75%.Battery was changed on (b)(6) 2019.No patient adverse events reported.
Additional Manufacturer Narrative
File was changed to non reportable per hazard code rmd-10001875.106-delay of therapy - minor-hazsit.339.This is a cadd battery pack, rechargeable, lithium ion, 3.7v, 1400.Initial report sent but correction made on the reportability to mdr=no.Battery only accepting 75% charge.Malfunction not likely to cause or contribute to death or serious injury.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.
Event or Problem Description
Information received a smiths medical cadd assessories battery will only charge and accept 75%.This is correction as this is changed to non reportable as it is a battery accessory.

• Brand Name: CADD ACCESSORIES BATTERY
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 lane n; minneapolis MN 55442
• MDR Report Key: 9566611
• Report Number: 3012307300-2020-00095
• Device Sequence Number: 2601009
• Product Code: MRZ
• UDI-Device Identifier: 10610586031212
• UDI-Public: 10610586031212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: BATTERY PACK, RECHARGEABLE, LITHIUM ION, 3.7V, 1400
• Device Catalogue Number: 21-2160-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1