MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRVASCULAR

Model Number 20027E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

The customer reported at 0600 the nurse attempted to attach primary line which contained tpn and lipids to a neutron cap.When attempting to attach the male luer it broke off.The user could not spike an additional bag of tpn until noon per pharmacy.The patient was started on a d5w iv fluids and blood sugars were monitored.There was no report of patient harm and blood sugars ran between 105 and 104.

Manufacturer Narrative

The customer¿s report of a broken male luer was confirmed.Visual inspection showed that the threaded locking collar was separated from the male luer and not received with the set.Limited functional testing was conducted due to the collar being separated and missing.Functional testing resulted in normal flow with no leaks observed.Pressure testing resulted in no leaks.The root cause of the reported event could not be determined.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, EXTENSION, INTRVASCULAR
• 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: 6122687
• MDR Text Key: 60747624
• Report Number: 9616066-2016-01623
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20027E
• Device Catalogue Number: 20027E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2017
• 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: (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR