MAUDE Adverse Event Report: CAREFUSION SD AS LVP 20D SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number	24001-0007
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.It was reported that the pump would not infuse while using the pump with the filter.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model spec18212 because an invalid lot number was provided by the customer.A device history record review could not be performed on model 24001-0007 because a lot number was not provided by the customer.Root cause analysis: due to no sample being received, an investigation could not be performed and a root cause could not be determined.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that as lvp 20d ss cv was occluded.The following information was provided by the initial reporter: material no: unknown filter batch no: unknown.It was reported would not infuse while using pump with filter.Can you please provide in details as to what really happened when the pump alarmed.What message did the alarm show (error code/message)? did the pump shut off (battery issue)? according to our clinical site, ¿occluded¿ was the alarm readout.The following is the summary of what happened with the pump: ¿on (b)(6) 2020 a iomab-b therapeutic infusion was performed for patient with a filter in the infusion line.The alaris pump alarmed shortly after starting the infusion, which is common based on clamping the lines, and the team was able to address the alarm and proceed with the infusion.Within approximately 30 minutes the pump alarmed again, and alarms continued to occur despite the team trying to resolve the source of the issue.The clinical site staff evaluated the issue and suspected the additional filter to be the source of the problem.The infusion was paused, a second filter was carefully back-primed and the original filter and the infusion restarted.The alarms continued and were becoming more frequent.After filter removal the patient was infused without further pump alarms¿.Was there any effects caused to the patient as a result of the event? any patient impact? the patient was infused.There was no patient impact.No saes reported.Can you please provide patient information/demographic? (weight, sex, age, diagnosis) we can¿t provide this information due to confidentiality.What was infusing into the pump? iomab-b therapeutic dose.

• Brand Name: AS LVP 20D SS CV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10570925
• Report Number: 9616066-2020-02865
• Device Sequence Number: 16892263
• Product Code: FPA
• UDI-Device Identifier: 10885403238666
• UDI-Public: 10885403238666
• 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: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: Other
• Device Model Number: 24001-0007
• Device Catalogue Number: 24001-0007
• Device Lot Number: UNKNOWN
• 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: 09/22/2020
• 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: Other