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

Model Number	10010483
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
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.Please note that this is not a late mdr submission but rather to provide the correct manufacturer report number from 2016493-2020-00379 (which was timely submitted on 03/26/2020 and but was inadvertently indicated as "instrument").Patient is a pediatric.Although requested, patient demographics was not provided.
Event or Problem Description
It was reported that the syringe adapter set broke at the top.It was noted that no medication was infusing at the time of the event.The event occurred in pediatrics unit.Although requested, additional information was not provided.
Event or Problem Description
It was reported that the syringe adapter set broke at the top.It was noted that no medication was infusing at the time of the event.The event occurred in pediatrics unit.Although requested, additional information was not provided.
Additional Manufacturer Narrative
The customer report that the syringe adapter set broke at the top was confirmed based on inspection of the as-received broken set.It was observed that the set's vented spike component was broken off from the upper fitment of the pump chamber assembly component.Further inspection of the broken vented spike component pieces observed the surfaces/breakage to be rough and uneven.The nature of the breakage indicates a ductile fracture (vs.A brittle fracture) that is typically caused by an external lateral force.The root cause of the external force was not identified.

• 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: 10003725
• Report Number: 9616066-2020-01498
• Device Sequence Number: 3387118
• Product Code: FPA
• UDI-Device Identifier: 10885403232602
• UDI-Public: 10885403232602
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K934095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: Health Professional
• Device Expiration Date: 11/07/2022
• Device Model Number: 10010483
• Device Catalogue Number: 10010483
• Device Lot Number: 19115457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 07/22/2020
• 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: 8100,8015,SYRINGE, TD UNK