MAUDE Adverse Event Report: CAREFUSION SD 8100 ALARIS PUMP MODULE; PUMP, INFUSION

Model Number 8100 ALARIS LVP MODULE

Device Problems Application Program Version or Upgrade Problem (2881); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

01/17/2018 12:57:47 (b)(6).Pmc? po: (b)(6).Shipping & billing addresses confirmed.(b)(6).On (b)(6) 2018, 19:59:57 (b)(6).Upgraded software to v9.17.0.22.Performed calibration.On (b)(6) 2018, 07:53:27 (b)(6).

Manufacturer Narrative

Note: this event was inadvertently reported under incorrect product registration number (manufacturer report number 9616066-2020-02807).This mdr resubmission now reflects the correct product registration number.This reported event and any subsequent repairs have been investigated through the normal service repair process.Failure data and parts used information, was reviewed for the sap file and track wise file, and found to be relevant to the service repair.A review of the source device service history record was performed beginning from the date of manufacture to the present date and indicated that this device has been previously returned for service.Service returns were for unrelated issues.The database showed no quality notifications were opened for the source device.A review of the device history record in sap for sn: (b)(4) was performed which confirmed that this device was not involved in a production failure and product was returned for the 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.

Manufacturer Narrative

Addition: updated adverse event codes (h6).

Event Description

On (b)(6)2018, 12:57:47, (b)(6).Pmc? po = (b)(6).(b)(6).Shipping & billing addresses confirmed.Npi.On (b)(6) 2018 ,19:59:57, (b)(6).Upgraded software to v9.17.0.22.Performed calibration.On (b)(6) 2018 07:53:27 (b)(6).(b)(4).

• Brand Name: 8100 ALARIS PUMP MODULE
• Type of Device: 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: 16047419
• MDR Text Key: 308539973
• Report Number: 2016493-2022-1179013
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8100 ALARIS LVP MODULE
• Device Catalogue Number: 8100 ALARIS LVP MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1