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

Model Number 20029E

Device Problem Fluid/Blood Leak (1250)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2016

Event Type  Injury  

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 a leak between the connection of the syringe and the filter.The tubing was replaced 3 times.The patient was with an open chest and unable to achieve diuresis.Once the infusion was changed to a bag with primary tubing, the patient had an immediate increase in urine output.There was no report of patient harm.

Manufacturer Narrative

Concomitant medical products: 3ml bd syringe ref 306508, lot 625812b, exp 2019-09-13, 0.9% sodium chloride injection, therapy date (b)(6) 2016.The customer¿s report of a leak was confirmed.Visual inspection was performed on the extension sets to look for defects such as cracks, kinks, tears and separations.Visual inspection found that the female luer set was joined with the male luer on the 30914.No defects were found anywhere on any extension set.Tactile examination found that the female luer was slightly unfastened to the male luer.Functional and pressure testing confirmed leaking only in a slightly unfastened state.Dimensional testing was performed on both the female luer of the extension set and the male luer of the extension set with go/no go gauges.Both parts were found to be within the required specifications.The root cause of the customer¿s report of a leak was determined to be due to a slightly unfastened connection between the male and female luer of the sets.

• 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: 6201034
• MDR Text Key: 63189560
• Report Number: 9616066-2016-01910
• 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,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2017
• 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: SYRINGE, (2) ME1250, 8015, 8100, TD
• Patient Outcome(s): Other
• Patient Age: 18 DA
• Patient Weight: 3