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

Model Number	10013072
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: one used non bd spike adapter; one used equashield connector; one used 250ml b braun, ref l8002, ndc 0264-7800-20, lot j8p017, exp 11/20, 0.9% sodium chloride injection; td: (b)(6) 2019.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
The customer reported that the tubing set separated during a rituximab 750mg/ns 270ml (with 20ml overfill) infusing at a rate of 23ml/hour (50mg/hour) with a total vtbi of 345ml.Although there was no patient harm, there was a slight delay in treatment.
Event or Problem Description
The customer reported that the tubing set separated during a rituximab 750mg/ns 270ml (with 20ml overfill) infusing at a rate of 23ml/hour (50mg/hour) with a total vtbi of 345ml.The patient required additional medications to counteract a medication reaction due to the event.
Additional Manufacturer Narrative
Concomitant medical products: delete pri tubing from initial report.The customer report that the tubing set separated was confirmed.Visual inspection showed a tear in the silicone segment at an area atop the lower fitment component.The tear measured approximately 0.05 inches in length.Functional testing and pressure testing resulted in an immediate leak from the observed tear.The root cause of the observed damage was not identified.
Event or Problem Description
The customer reported that the tubing set separated during a rituximab 750mg/ns 270ml (with 20ml overfill) infusing at a rate of 23ml/hour (50mg/hour) with a total vtbi of 345ml.Although there was no patient harm, there was a slight delay in treatment.

• 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: 8360764
• Report Number: 9616066-2019-00409
• Device Sequence Number: 2306723
• Product Code: FPA
• UDI-Device Identifier: 07613203021210
• UDI-Public: 7613203021210
• 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,Followup
• Report Date (Section B): 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10013072
• Device Catalogue Number: 10013072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/26/2019; 04/29/2019
• 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: 8100,8015, PRI TUBING, TD 01/18/2019; SEC TUBING, TD 01/18/2019; SECONDARY SET, TD 01/18/2019; 8100,8015, PRI TUBING, TD: (B)(6) 2019.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR