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

Model Number 8015

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/07/2023

Event Type  malfunction  

Manufacturer Narrative

Bd technical support troubleshoot with customer over the phone.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.Per 803.52(f)(11)(iii), the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.H3 other text: device was not returned to manufacturing facility.

Event Description

It was reported that the pcus with newer batteries were unable to "pass" the battery conditioning test (results ranging from 3801 mah to 3942 mah).There was no patient involvement as the issue occurred during device maintenance.Bd technical support reached out to the customer and provided the following guidance: a copy of service bulletin 638a release of bd alaris¿ system v12.1.2 and service bulletin 592a updated battery care and battery conditioning test was provided to the customer.Additionally, bd technical support informed the customer that "per the service bulletin 592a updated battery care and battery conditioning test, if the new battery capacity value is between 4000 mamphr (mah) and 4500 mamphr (mah), then the battery capacity is sufficient for use.However, this is an overestimate of the actual battery capacity.This applies to newly installed batteries.Then the unit would need to have reset the battery capacitance.This only applies to units that have point of care version 12.1.0 and earlier.Per service bulletin 638a release of bd alaris¿ system v12.1.2, the battery over estimation was corrected.When performing the battery recondition with version 12.1.2 and above, the acceptable range between 3700 mamphr (mah) and 4500 mamphr (mah)." service bulletin 592a updated battery care and battery conditioning test also notes that "if the new battery capacity is between 3700 mamphr (mah) and 3999 mamphr (mah), you can perform the manual battery conditioning test on page 5 to get a more accurate estimate of battery capacity to determine whether the battery can be used.Alternatively, replace with a new battery.Proceed to step 11 to power down the device and complete the test.If the new battery capacity is less than 3700 mamphr (mah) or greater than 4500 mamphr (mah), this is outside the range of acceptable battery capacity reading.Proceed to step 11 to power down the device and complete the test.Replace with new battery." after bd technical support team reviewed the spreadsheet (listing the battery conditioning test values) provided by the customer, it was concluded that "the units are working as intended and are within the acceptable range.".

• Brand Name: ALARIS SYSTEM
• 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: 17867311
• MDR Text Key: 324873936
• Report Number: 2016493-2023-235143
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801549
• UDI-Public: (01)10885403801549
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8015
• Device Catalogue Number: 8015 ALARIS PCU 1.5 MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2018
• 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