MAUDE Adverse Event Report: CAREFUSION SD 8600 ALARIS AUTO-ID MODULE; PUMP, INFUSION

Model Number	8600
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This reported event and subsequent repairs were investigated through the service repair process.Failure data and parts-used information were reviewed for the sap and track wise files and found relevant to the service repair.A review of the source device service history record was performed from the date of manufacture to the date corresponding to this service notification number.The database showed no quality notifications were opened for the device.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.The customer stated that there was no patient involvement.
Event or Problem Description
(b)(4).
Event or Problem Description
Pcu will not recognize auto-id.Logic board- faulty.(b)(4).There was no patient involvement.(b)(4).

• Brand Name: 8600 ALARIS AUTO-ID MODULE
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10842777
• Report Number: 2016493-2020-40714
• Device Sequence Number: 11378239
• Product Code: FRN
• UDI-Device Identifier: 10885403860003
• UDI-Public: 10885403860003
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K041241
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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: 8600
• Device Catalogue Number: 8600
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1