MAUDE Adverse Event Report: CAREFUSION SD ALARIS PUMP MODULE; PUMP, INFUSION

Model Number	8100
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
An 8100 lvp was identified as being affected by the bezel mechanical assembly recall.This event is reported retrospectively as a presumptive malfunction report.
Additional Manufacturer Narrative
At the time of the reported field action, customers were notified.Device repair or returns were handled within the scope of the field action.No further information is available as this is a retrospective report based on field action affected serial numbers dating back to 2011.Device not available for evaluation.

• Brand Name: ALARIS PUMP MODULE
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 13745281
• Report Number: 2016493-2022-713490
• Device Sequence Number: 5426028
• Product Code: FRN
• UDI-Device Identifier: 10885403222054
• UDI-Public: 10885403222054
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

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: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2011
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1768-2019
• Patient Sequence Number: 1
• Patient Sex: Unknown