MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number PRI TUBING

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)

Patient Problem Death (1802)

Event Date 05/22/2015

Event Type  Death  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that during the process of adding another iv set to infuse an unspecified medication, the user noted that a previously established iv set began infusing inadvertently, and an entire bag with epinephrine 5mg/255ml infused.The patient had a stroke and subsequently died.The clinician said the event occurred due to a device failure and not human error.The devices were evaluated by the biomedical department at the facility and returned to service.The customer stated that the event disposable set was not saved; although no testing was performed on the set, they reported that it was expected that the safety clamp would engage and the roller clamp was not employed when the nurse removed the tubing from the pump.

Manufacturer Narrative

Additional information provided: serial numbers for concomitant devices are (8015) s/n (b)(4) and (8100) s/n (b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

On initial report: the suspect product is now a device rather than a disposable and requires a new manufacturer report number.Please reference manufacturer report number 2016493-2017-00243 for mdr reporting.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5899917
• MDR Text Key: 52858179
• Report Number: 9616066-2016-01160
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death