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

Model Number	20043E
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was an infant.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 or Problem Description
It was reported that the tubing cracked and caused significant blood loss when connected to the arterial line of a neo-natal patient.The infant lost approximately 40ml of blood and required a blood transfusion.There was no lasting harm.
Additional Manufacturer Narrative
The customer¿s complaint that the tubing cracked and leaked could not be confirmed because the product was not returned for failure investigation.Photo(s) provided by the customer shows the suspect extension set inside a biohazard bag connected to an unknown syringe.The root cause of this failure could not be identified.
Event or Problem Description
It was reported that the tubing cracked and caused significant blood loss when connected to the arterial line of a neo-natal patient.The infant lost approximately 40ml of blood and required a blood transfusion.There was no lasting harm.

• 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: 8811769
• Report Number: 9616066-2019-01969
• Device Sequence Number: 2119300
• Product Code: FPA
• UDI-Device Identifier: 10885403234873
• UDI-Public: 10885403234873
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 06/24/2019

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 Model Number: 20043E
• Device Catalogue Number: 20043E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 4