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	Inadequate Pain Relief (2388)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: value analysis and resource utilization.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 omnipaque 350 contrast administration during a ct scan.The tubing set leaked near the connection site at the end closest to the patient with some blood loss.The split in the tubing was approximately 1cm long.The highest pressure recorded on the omnipaque was 220psi; highest flow rate recorded: 2.5ml/sec.The patient was initially completing the ct scan while asleep however due to the event and prolonged time to change the tubing, the patient woke up and subsequently required additional sedation to complete the imaging.There was no lasting effect to the patient.
Additional Manufacturer Narrative
The customer¿s report of a t-connector "ruptured" and leaked during omnipaque 350 contrast administration was confirmed.Visual inspection of the set noted a rupture split just above the set¿s male luer.No other anomalies were noted.Functional testing was deemed unnecessary due to the damage.The root cause of the rupture split tubing was determined to be due to an excessive amount of pressure, reported as 220psi by the customer.Per the set¿s design specifications, this is not a pressure rated extension set and was not designed to function at the customer¿s reported use pressure.
Event or Problem Description
It was reported that a t-connector "ruptured" during omnipaque 350 contrast administration during a ct scan.The tubing set leaked near the connection site at the end closest to the patient with some blood loss.The split in the tubing was approximately 1cm long.The highest pressure recorded on the omnipaque was 220psi; highest flow rate recorded: 2.5ml/sec.The patient was initially completing the ct scan while asleep however due to the event and prolonged time to change the tubing, the patient woke up and subsequently required additional sedation to complete the imaging.There was no lasting effect to the patient.

• 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: 8645796
• Report Number: 9616066-2019-01383
• Device Sequence Number: 11266824
• 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: Non-Healthcare Professional
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: C20025
• Device Catalogue Number: C20025
• Device Lot Number: 18065291
• 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: 05/28/2019
• Supplement Report FDA Received Date: 09/03/2019
• 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: C20025,NON-BD MICROCLAVE, TD (B)(6) 2019
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 MO
• Patient Weight: 5