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

Model Number	10927766
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional information including patient's demographics requested, but was not provided.
Event or Problem Description
It was reported that the iv tubing set separated and leaked.Additional information requested, but was not provided.
Additional Manufacturer Narrative
The customer's report that the tubing set separated and leaked was confirmed.The primary set sample was visually inspected for kinks, holes/tears in the tubing or damages to the components.The set was received separated at the engagement between the silicone segment and lower fitment components.The expected retainer ring at the separated area was not received.The affected components were measured to be within specification(s).Further inspection of the separated silicone segment end observed evidence of a retainer ring indentation which does not look to be misaligned along the tubing, indicating that it had been properly assembled onto the set.The cause of the leak was due to the observed separation.The root cause of the separation was not identified.
Event or Problem Description
It was reported that the iv tubing set separated and leaked.Although requested, there has been no impact to patient response or additional event information made available to date.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9845022
• Report Number: 9616066-2020-00790
• Device Sequence Number: 11470537
• Product Code: FPA
• UDI-Device Identifier: 07613203019101
• UDI-Public: 7613203019101
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 10927766
• Device Catalogue Number: 10927766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/21/2020
• 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: 8015,8100,20027E, THERAPY DATE UNK