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

Model Number 2426-0500

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2018

Event Type  Injury  

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

Received a copy of the customer's medwatch report from fda, which states ¿pt was getting a ct scan.Vasoactive meds and propofol infusing.Pt not getting sedated.Noted puddle on the floor before the pump.Noted hole in tubing." an incomplete date of event of (b)(6) 2018 was provided.The customer later reported that there was no harm caused to the patient from the event.

• 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: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7576642
• MDR Text Key: 110322198
• Report Number: 9616066-2018-00765
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Other Device ID Number: 7613203020992
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/06/2018
• 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): Other
• Patient Age: 55 YR