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

Model Number	2429-0500
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
It was reported that during and infusion in the oncology department, the primary iv tubing set leaked stem cells at the hub nearest the patient, the patient lost 1mlof stem cells.The tubing set was replaced and the infusion restarted with no further incidents.There was no patient impact.
Event or Problem Description
It was reported that during and infusion in the oncology department, the primary iv tubing set leaked stem cells at the hub nearest the patient.The patient lost 1ml of stem cells.The tubing set was replaced and the infusion restarted with no further incidents.It was further confirmed during follow up, that it is unknown if there was any patient harm or impact as a result of this event.Although requested, there has been no response to patient impact or additional event information made available to date.
Additional Manufacturer Narrative
Additional updated information: b.5.
Event or Problem Description
It was reported that during and infusion in the oncology department, the primary iv tubing set leaked stem cells at the hub nearest the patient., the patient lost 1ml of stem cells.The tubing set was replaced and the infusion restarted with no further incidents.It was further confirmed during follow up, that it is unknown if there was any patient harm or impact as a result of this event.Although requested, there has been no impact to patient response or additional event information made available to date.
Additional Manufacturer Narrative
The customer's report that the tubing set leaked at the hub nearest the patient was confirmed.The set sample was visually inspected for kinks, holes/tears in the tubing or damages to the components.No issue was observed.The set was re-primed and no leak or issue was observed.Visual inspection observed that the leak was at the engagement of the pvc tubing to the inlet of the bottom smartsite port.Further inspection of the leaking tubing end shows the tubing's outer diameter to be out of specification.Functional testing was performed; fluid was leaking from the engagement of the pvc tubing.The root cause that the tubing set leaked at the hub nearest the patient was a supplier/manufacturing issue.

• 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: 9490326
• Report Number: 9616066-2019-03624
• Device Sequence Number: 296801
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2019

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: 2429-0500
• Device Catalogue Number: 2429-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 03/03/2020; 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 163