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

Model Number 10014916

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 08/14/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant medical devices: bd 60ml syringe, therapy date (b)(6) 2016.The customer¿s report that the set cracked and leaked was confirmed.During visual inspection it was noted that the female luer had a vertical hair line crack that measured 0.425 inches long.Inspection of the luer under magnification showed no stress marks.Functional testing was performed and a leak was observed flowing through the crack on the female luer.The probable cause of the breakage was identified as a combination of material degradation during the supplier process and manufacturing factors (solvent and over-torque).

Event Description

The customer reported that the set leaked from a cracked luer during an infusion of epinephrine, dosage and rate not provided.Reportedly the patient "coded due to a loss of blood pressure medication and fluid resuscitation was performed." there was no lasting patient harm.

• Brand Name: ALARIS SYRINGE MODULE 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: 5937961
• MDR Text Key: 54262961
• Report Number: 9616066-2016-01202
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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, MZ1000, TD
• Patient Outcome(s): Required Intervention