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

Model Number 8100

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) evaluation statement: the reported event of a check iv set alarms could not confirmed.No product or event logs have been returned for this investigation.File was opened to document an event that the customer reported.No further investigation of this event is possible at this time.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 not returned for the servicing which not 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.Capa reference: (b)(4).

Event Description

The customer reported that the channel continually alarmed "check iv set" despite the tubing being removed.  it took 3 attempts to get the pump to turn off and stop alarming.  the channel was infusing fentanyl at 0.5 ml/hr.There was no harm to the patient. biomed reported changing the "check iv set assembly.".

• 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: madhavan ezhumalai ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 10611038
• MDR Text Key: 222204559
• Report Number: 2016493-2020-14286
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2010
• 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