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

Model Number	10798703
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Concomitant medical products: 250ml baxter bag loth938737 eva container.The event reportedly occurred in the nicu; therefore it is presumed the patient was a (b)(6).
Event or Problem Description
It was reported that the tubing severed during a transporting a nicu patient in the incubator.The staff states: the line did not come in contact with any sharp object.There was no reported harm to the patient per customer.
Additional Manufacturer Narrative
The customer's report that the tubing broke and leaked was confirmed.Visual inspection of the set was done for obvious issues/damage such as kinked tubing, pin holes, tears, disengagements, cracks, fractures, contaminants, incorrect orientation, and component misassembly.During visual inspection, it was observed that the micro-bore tubing was cut approximately 2 1/2 inches below the pressure sensing disc component.Inspection under magnification of the cut tubing end observed a sliced cut.No other obvious damages were observed around the cut tubing area.The cause of the leak was due to the damaged tubing.The root cause of the damage was not identified.
Event or Problem Description
It was reported that an rn noticed the tubing severed during the transporting of a nicu patient in the incubator.The staff stated; "the line did not come in contact with any sharp object".Per the customer, there was no reported harm to the patient.

• 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: 8791405
• Report Number: 9616066-2019-01891
• Device Sequence Number: 16779179
• Product Code: FPA
• UDI-Device Identifier: 10885403234378
• UDI-Public: 10885403234378
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K811885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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 Expiration Date: 05/30/2021
• Device Model Number: 10798703
• Device Catalogue Number: 10798703
• Device Lot Number: 18055427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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: 8015,8100, INCUBATOR, TD (B)(6) 2019