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

Model Number 8100

Device Problem Disconnection (1171)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/20/2019

Event Type  Injury  

Manufacturer Narrative

No device will be returned per customer.The customer complaint could not be confirmed because the device was not returned for failure investigation.The root cause of this failure was not identified.Admitting diagnosis: septic shock and pancytopenia.

Event Description

It was reported that during an infusion of a high dose norepinephrine, the channel had 2 episodes of disconnection and could not be reconnected by multiple nurses.It was noted that the patient's blood pressure was significantly impacted resulting to an addition of epinephrine and phenylephrine infusions.The event occurred at the intensive care unit.Per non-bd biomedical engineer, devices were inspected and no issues were found.Risk authorization cleared them for release and all devices were placed back in service.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: joyce muthama ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9955951
• MDR Text Key: 190922435
• Report Number: 2016493-2020-00538
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR