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

Model Number	10933805
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Patient information has been requested, but not provided.
Event or Problem Description
It was reported that during a chemotherapy (cytarabine) infusion, the primary tubing line was cracked, which caused leaking.The clinician reported the leak to be approximately 50cc.The patient was exposed to the leaked (cytarabine) that was on the floor when she stepped in it, unknowingly with her foot.The therapy was delayed approximately 1.5 hours due to re-mixing.Although, it was reported that patient care was delayed it did not contribute to, or result in serious adverse impact to patient or the caregiver.
Additional Manufacturer Narrative
Additional information added to: d.10.A visual inspection of pumping segment tubing damage and leak was confirmed based on visual inspection.A tear was observed in the silicone segment directly below the upper fitment component.The tear in the silicone segment directly below the upper fitment component extended 3/4 around the tubing.It is unknown how the damage occurred.The set was inspected for kinks, holes/tears in the tubing or damages to the components.No testing was deemed necessary due to the obvious damage.The root cause of the damage was not identified.
Event or Problem Description
It was reported that during a chemotherapy (cytarabine) infusion, the primary tubing line was cracked, which caused leaking.The clinician reported the leak to be approximately 50cc.The patient was exposed to the leaked (cytarabine), that was on the floor when she stepped in it unknowingly with her foot.The therapy was delayed approximately (1.5) hours due to re-mixing.Although, it was reported that patient care was delayed, it did not contribute to, or result in any serious adverse impact to patient or to the caregiver.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9297161
• Report Number: 9616066-2019-03207
• Device Sequence Number: 468033
• Product Code: FPA
• UDI-Device Identifier: 07613203019088
• UDI-Public: 7613203019088
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/18/2019

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: 10933805
• Device Catalogue Number: 10933805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1