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

Model Number 10014916

Device Problem Fluid/Blood Leak (1250)

Patient Problems Underdose (2542); No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: microclave; bd 10ml syringe ref (b)(4), lot 7164864, exp (b)(6) 2020, 0.9% nacl (milrinone); 10ml bd syringe ref (b)(4), lot number 7206535, exp (b)(6) 2020, 0.9% nacl, therapy date (b)(6) 2017.The affected product has been received.A follow up report will be submitted with investigation results.

Event Description

The customer reported that when the patient arrived in the picu from the operation room, milrinone was seen leaking from the 0.2 micron filter in the syringe pump tubing.There was no report of patient harm.

Manufacturer Narrative

(b)(4).The customer¿s report of a leak from the filter was confirmed.Visual inspection under magnification did not show any gaps at the engagement of the microbore tubing to the filter outlet and the tubing remained securely attached when tugged.Functional testing confirmed leaking at the tubing to filter engagement.During testing fluid movement was observed between the outer wall of the tubing and the inner wall of the filter outlet port, indicating a solvent channel.Dimensional testing was performed and the set was within specification.The cause of the leak was identified as insufficient/lack of solvent being applied at the affected engagement, attributed to equipment and/or operator error during assembly.

• Brand Name: ALARIS SYRINGE MODULE SETS
• 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: 7003408
• MDR Text Key: 91340948
• Report Number: 9616066-2017-01421
• 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: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

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: 10014916
• Device Catalogue Number: 10014916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 12/01/2017
• 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