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

Model Number	10800173
Medical Device Problem Codes	Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 10ml bd syringe, lot: 9142911, exp: 2022-05-31, 0.9% sodium chloride injection.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 or Problem Description
It was reported that the tubing set leaked from the engagement at the y-site during a dilaudid and iv fluid infusion.It was clarified that the tubing set did not separate as initially reported.The patient did not receive any of the iv fluid flush bag and it is undetermined whether the patient received the dilaudid medication as ordered, however, the customer further stated that there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
The customer¿s report that the tubing set leaked was confirmed, however; the leak is from a crack in the female luer, not from the y-site as the customer reported.Visual inspection confirmed that the female luer had a lateral crack.Closer inspection under a lab microscope observed no tool marks or signs of over torque.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection found a crack in the female luer wall on the opposite end of the injection gate of the suspect pca set.No tool marks or signs of over torque were observed.A lab syringe was attached to the set for a priming test, and the set leaked from the cracked female luer.No other leaks were observed throughout the set.The root cause was identified to be a result of internal stresses created during the manufacturing process that make it more susceptible to chemical/mechanical attacks.
Event or Problem Description
It was reported that the tubing set leaked from the engagement at the y-site during a dilaudid and iv fluid infusion.It was clarified that the tubing set did not separate as initially reported.The patient did not receive any of the iv fluid flush bag and it is undetermined whether the patient received the dilaudid medication as ordered.The customer further stated that there were no adverse effects caused to the patient from the event.

• Brand Name: ALARIS PCA MODULE EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9123138
• Report Number: 9616066-2019-02687
• Device Sequence Number: 2819433
• Product Code: FPA
• UDI-Device Identifier: 10885403234385
• UDI-Public: 10885403234385
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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
• Operator of Device: Health Professional
• Device Model Number: 10800173
• Device Catalogue Number: 10800173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100, 8015, 2420-0007, THERAPY DATE (B)(6) 2019; 8100, 8015, 2420-0007, THERAPY DATE (B)(6) 2019
• Patient Age: 45 YR