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

Model Number	2478-0000
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 500ml blood bag, lot: 11320353am, exp: 18feb2020; 250ml baxter bag, lot: y325464, exp: jun21, 0.9% sodium chloride injection, therapy date (b)(6) 2020.The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.Patient's demographics, was not provided.
Event or Problem Description
It was reported that during an infusion, the blood infused within minutes instead of hours.There was no patient impact.
Event or Problem Description
It was reported that during an infusion, the blood infused in minutes instead of one hour.The blood was programed to infuse at a rate of 250ml/hr with volume to be infused (vtbi) of 250 ml for a duration of 1 hour.It was further confirmed during follow up that patient care was not delayed and that this event did not contribute to, or result in a serious adverse impact to patient.
Additional Manufacturer Narrative
Additional and updated information: b.5, d.11.The customer's report that blood infused in minutes instead of one hour was not confirmed.The set sample was inspected for kinks, holes/tears in the tubing or damages to the components.No issue was observed.The set's directions for use state to open only one upper clamp to allow flow from the desired container during an infusion and the infusions completed as expected with no issue.Rate accuracy testing observed no issue.Inspection of dissected areas of the silicone segment observed no issues with its concentricity.The root cause that blood infused in minutes instead of one hour was unable to be identified.

• Brand Name: ALARIS PUMP MODULE BLOOD SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9760206
• Report Number: 9616066-2020-00585
• Device Sequence Number: 11457765
• Product Code: FPA
• UDI-Device Identifier: 10885403235122
• UDI-Public: 10885403235122
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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 Expiration Date: 12/23/2022
• Device Model Number: 2478-0000
• Device Catalogue Number: 2478-0000
• Device Lot Number: 19126935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 05/05/2020
• 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
• Patient Age: 58 YR
• Patient Weight: 78