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

Model Number	10927766
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 100ml hospira bag, lot#: 96-091-jt, exp: 1 dec 2020, metronidazole injection.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that tubing backflows into primary.
Event or Problem Description
It was reported that tubing backflows into primary.Customer advocacy received a copy of the customer's medwatch report which states, "situation, two bd alaris tm pump infusion sets have been confirmed to have faulty back check valves the events were identified when piggybacking a secondary infusion into the primary set the secondary bag rapidly emptied into the primary drip chamber filling and bubbling into the primary bag these two events were caught prior to reaching the pts fda safety report id # (b)(4).".
Additional Manufacturer Narrative
The customer¿s report of secondary back flowed into primary bag was confirmed.The primary set and secondary sets were visually inspected for incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted no damage or any anomalies.The check valve was visually inspected under magnification and was noted to be assembled in the set correctly, and the silicone membrane was centered.Functional testing resulted in fluid and air bubbles going into the primary bag.Disassembly of the check valve resulted in check valve disc being pinch within housing.The root cause of the customer¿s report of secondary back flowed into primary bag was caused by the check valve disc being pinched which is a supplier-related issue.A pinch disc would lead to a failure of the check valve.
Additional Manufacturer Narrative
Additional medwatch information provided.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report which states, "situation, two bd alaris tm pump infusion sets have been confirmed to have faulty back check valves the events were identified when piggybacking a secondary infusion into the primary set the secondary bag rapidly emptied into the primary drip chamber filling and bubbling into the primary bag these two events were caught prior to reaching the pts fda safety report id # (b)(4).".

• 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: 8967286
• Report Number: 9616066-2019-02436
• Device Sequence Number: 2150795
• 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,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2019

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: 10927766
• Device Catalogue Number: 10927766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/02/2019; 12/04/2019
• 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: 11448964, 500ML BAXTER BAG, TD (B)(6) 2019