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

Model Number	C20025
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that a t-connector ruptured during contrast administration while connected to a patient during a ct scan.The tubing set ruptured in the center of the tubing creating some blood loss.The rupture was approximately 1.5cm long.They were administering omnipaque 350, highest pressure recorded: 270psi , highest flow rate recorded: 5.05ml/sec.There was no harm.
Event or Problem Description
It was reported that a t-connector ruptured during contrast administration while connected to a patient during a ct scan.The tubing set ruptured in the center of the tubing creating some blood loss.The rupture was approximately 1.5cm long.They were administering omnipaque 350, highest pressure recorded; 270/psi, highest flow rate recorded; 5.05ml/sec.There was no patient harm reported.
Additional Manufacturer Narrative
The customer¿s report of a t-connector rupture during contrast administration was confirmed.Visual inspection noted the set had ruptured tubing.The rupture was five inches above the set¿s male luer and was approximately 0.5150 inches long.The set was also visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No other abnormalities were observed on the set during visual inspection.Due to the damage to the tubing, no functional testing was performed.The root cause of the ruptured tubing was determined to be an excessive amount of pressure, reported as 270psi by the customer, being applied to the non-pressure rated set.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8615671
• Report Number: 9616066-2019-01382
• Device Sequence Number: 2074630
• Product Code: FPA
• UDI-Device Identifier: 10885403235504
• UDI-Public: 10885403235504
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 05/01/2019

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: C20025
• Device Catalogue Number: C20025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 127