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

Model Number	11059728
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/15/2019
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.
Event or Problem Description
It was reported that tubing came apart at the connection and leaked when the patient was repositioning.There was an unknown amount of medication given ¿ small amount of blood loss: high risk of blood loss and high risk of infection."tubing was disposed of due to the level of contaminate.".
Event or Problem Description
It was reported that tubing came apart at the connection and leaked when the patient was repositioning.There was an unknown amount of medication given ¿ small amount of blood loss: high risk of blood loss and high risk of infection."tubing was disposed of due to the level of contaminate.".
Additional Manufacturer Narrative
No product will be returned per customer.No investigation was performed.A photo of a 4-way stopcock connected to a female and male luer was provided by the customer.No separations or leaks could be confirmed based on the photo.The root cause of this failure was not identified as no product was returned.

• 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: 8894812
• Report Number: 9616066-2019-02246
• Device Sequence Number: 371992
• Product Code: FPA
• UDI-Device Identifier: 10885403234644
• UDI-Public: 10885403234644
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 07/17/2019

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: 11059728
• Device Catalogue Number: 11059728
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1