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

Model Number 8100

Device Problem Material Fragmentation (1261)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record showed the device had a manufacture date of 23jul2010.The review was performed from the date of manufacture to the date of product release for distribution.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 which correlates to the customer reported issue.A review of the complaint history record was performed for the sn (b)(4) which did not confirm similar complaints with the same or related failure mode for this customer.

Event Description

It was reported that the device has broken tabs and needs a new bezel.No additional information was provided.There was no patient involvement.

Event Description

It was reported that the device has broken tabs and needs a new bezel.No additional information was provided.There was no patient involvement.

Manufacturer Narrative

This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that they replaced bezel due to broken upper sensor clip damage.Replaced ail (chipped right set guide damaged).Replaced upper pressure sensor for check iv set.Replaced door (cosmetic defect).Replaced discolored membrane.Rear case recall completed.A review of the device history record showed the device had a manufacture date of 07/23/2010.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.Based on the findings, service determined that the proximate cause of the reported issue was due to customer damage of the bezel assembly - upper sensor clip damage.During servicing we identified faulty pressure sensor which constitutes a reportable malfunction.There was no patient involvement.A bottle side (upper) pressure sensor failure was confirmed and replicated during testing.Testing of the returned alaris¿ pump model 8100 confirmed that the bottle side pressure sensor was faulty.The pressure sensor was replaced with a known good part and allowed to infuse with no alarms or malfunctions occurring.A patient side (upper) pressure sensor failure was confirmed and replicated during testing.Testing of the returned alaris¿ pump model 8100 confirmed that the patient side pressure sensor was faulty.The pressure sensor was replaced with a known good part and allowed to infuse with no alarms or malfunctions occurring.A review of the complaint history record in trackwise and sap was performed for the sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.There are capa #'s noted for the following parts replaced that have an already existing capa.Ca-2014-0284 lvp air-in-line.Capa pa-2014-0026 lvp pressure sensor.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11329746
• MDR Text Key: 231986853
• Report Number: 2016493-2021-26141
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0950-2017
• Patient Sequence Number: 1