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

Model Number 10014916

Device Problem Fluid/Blood Leak (1250)

Patient Problems Therapeutic Response, Decreased (2271); Underdose (2542)

Event Date 10/06/2017

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

The customer reported that nicardipine was infusing during transport from the operating room to the picu; however, the patient was not responding to the medication.The set was evaluated and fluid was seen leaking from the 0.2 micron filter in the tubing.The customer reported the patient required intervention but the type was not provided.There was no report of lasting harm.

Event Description

Received a copy of the customer's medsun report from the fda which states, "event description information is on page 3." the event date is listed as (b)(6) 2017.Concomitant therapies included cardiac drugs, tpn/iv fluids.However, the text on page 3 is illegible.The customer was contacted for clarification and provided the following description: "event 5.Date: (b)(6) 2017.Pt arrived from or.Had nicardipine gtt infusing but not responding to it.Bp still high.Discovered iv tubing to be leaking at filter site.Do not have cat number.".

• Brand Name: ALARIS SYRINGE MODULE SETS
• 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: 7003221
• MDR Text Key: 91092700
• Report Number: 9616066-2017-01420
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10014916
• Device Catalogue Number: 10014916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• 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
• Treatment: 8110,8015, THERAPY DATE UNK
• Patient Outcome(s): Required Intervention