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

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Split (2537)

Patient Problem Blood Loss (2597)

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Event Description

The customer reported that the tubing split open and the patient lost a lot of blood.There was no report of patient harm or medical intervention.No additional patient or event details were provided by the customer.

Manufacturer Narrative

Concomitant medical products: icu medical set with bonded clear micro clave; bd 3ml syringe; model/ lot # unk; therapy date: (b)(6) 2015.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Manufacturer Narrative

No available code for undetermined or unknown cause.The customer¿s report of the tubing being split open was confirmed.Visual inspection and the gravity test found a.17 inch slice in the tubing that was approximately 6.5 inches above the distal smartsite.Further examination noted a smartsite with the piston in a depressed state where the extension set was attached.Functional testing detected a leak on the tubing during a gravity infusion.No immediate functional issue was found with the depressed smartsite piston.Pressure testing found the set to leak at 3 psi.The root cause of the split on the tubing is unknown but the slice cut seems consistent with damage that has occurred from a puncture with a box cutter or a similar sharp object used to open the packaging.The root cause for the depressed smartsite is unknown.

• 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: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 5053544
• MDR Text Key: 24932328
• Report Number: 9616066-2015-01079
• 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
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2016
• 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