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

Model Number	11059728
Medical Device Problem Codes	Backflow (1064); Disconnection (1171)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.Patient age and dob requested but not provided.
Event or Problem Description
It was reported that the anesthesiologist removed the gravity tubing set from the package and tightened all of the connections prior to attaching to the patient.During the induction procedure, the anesthesiologist noted that the tubing set unintentionally disconnected and leaked approximately 20ml of the patient's blood.It was further stated that when the anesthesiologist tightens the tubing sets fixed male luer to prevent further unintentional disconnects, the male luer cracked.

• Brand Name: ALARIS® GRAVITY ADMINISTRATION SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9414251
• Report Number: 9616066-2019-03475
• Device Sequence Number: 17176209
• Product Code: FPA
• UDI-Device Identifier: 10885403234644
• UDI-Public: 10885403234644
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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
• Report Date (Section B): 11/11/2019

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: 11059728
• Device Catalogue Number: 11059728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1