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

Model Number	11607704
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the iv tubing set broke and content spilled.
Additional Manufacturer Narrative
The customer's report that the iv tubing set broke and spilled its contents was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted a horizontal tear in the silicone tubing below the upper fitment retainer ring.No gouge/crush marks were observed on the upper fitment.Clear liquid was observed in the drip chamber and entire length of tubing.No other abnormalities were observed.Functional and pressure testing confirmed leaking from the tear in the silicone tubing.The cause of the leak was due to the tear in the tubing.The root cause of the tear could not be determined.
Event or Problem Description
It was reported that the iv tubing set broke and spilled its contents.Although requested, there is no additional patient or event information available.
Additional Manufacturer Narrative
Additional information provided: b.5.Patient's demographics requested, but was not provided.
Event or Problem Description
It was reported that the iv tubing set broke and spilled its contents when chemotherapy was being hung via the primary tubing on the pump module attached to an iv pole.There was no patient impact.

• 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: 9188386
• Report Number: 9616066-2019-02869
• Device Sequence Number: 3642866
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2019

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: 11607704
• Device Catalogue Number: 11607704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 12/16/2019; 01/07/2020
• 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: ORANGE ALCOHOL DISINFECTING CAP, TD (B)(6) 2019.