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

Model Number 20029E

Device Problem Fluid/Blood Leak (1250)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 02/11/2018

Event Type  Injury  

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 that an open chested post-operative patient was receiving infusions of fentanyl, dopamine, epinephrine, milrinone, precedex and maintenance iv fluids when the rn noted the bed linen was damp at the start of the shift.A small chux was placed under the connection of the iv tubing.Later the rn noticed the connection between the fentanyl tubing and filter was damp.A new filtered tubing was used and the rn noted the patient was then resting better and calmer and the site was no longer damp.Later in the day the rn noticed the same issue and changed the tubing for the second time with no further issues.As a result of the tubing leak the patient required prn pain medication and an increase in the fentanyl dose.There was no lasting harm.

Manufacturer Narrative

Correction on initial report: disregard initial submission; the extension set model 30914, originally listed as a concomitant product, was identified to be the single suspect product and the cause of the ongoing leak (which was perceived by the user as 2 separate leak events).Refer to related mdr report 9616066-2018-00364.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, EXTENSION, 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: 7386066
• MDR Text Key: 103973694
• Report Number: 9616066-2018-00401
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20029E
• Device Catalogue Number: 20029E
• Other Device ID Number: 10885403234866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2018
• 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
• Treatment: 30914, THERAPY DATE (B)(6) 2018
• Patient Outcome(s): Required Intervention
• Patient Age: 21 DA
• Patient Weight: 3