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

Model Number 8100

Device Problems Device Sensing Problem (2917); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s reported event of repeated air in line alarms were confirmed during a log analysis.However, false ail alarms were not replicated while testing both customer devices during the investigation.Log analysis results confirmed the presence of 1 ail alarm on pump module s/n (b)(4) and 10 ail alarms on pump module s/n (b)(4) on (b)(6) 2019.Ail test method results, consisting of a one hour test infusion and ail ultrasonic signal measurements confirmed that customer¿s.Pump modules ail assemblies are operating as intended.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.

Event Description

Complaint-(b)(4)- air in line alarms.Ail sensor assy- faulty.The customer reported that during induction of anesthesia the propofol infusion was started which caused an "air in line" (ail) alarm on the pump.The tubing was inspected for air and after discovering no air the line was returned to the pump and the infusion was restarted.The same error message appeared causing the infusion to stop.The propofol tubing was moved to a different pump and that pump displayed the same message of ail.A new propofol vial and tubing was inserted into the pump and the device alarmed again for ail.The propofol was then drawn up into a 60ml syringe and placed on a syringe pump for the remainder of the procedure.Although requested, there were no further details or information provided and no report of harm.

• 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: anand raj gopalan ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11103496
• MDR Text Key: 249159439
• Report Number: 2016493-2020-86686
• 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: health professional,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2004
• 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