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

Model Number	C24103E
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported the nurse noticed a hole on the pump segment near upper fitment of the iv tubing that caused leak.It was not known if the event occurred during infusion or priming.The customer provided photo of the tubing.
Additional Manufacturer Narrative
The customer's report of a leak and hole on the pump segment near upper fitment 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 small hole in the silicone tubing below the set's upper fitment retainer ring.A gouge/crush mark was observed on the set¿s upper fitment just above the hole in the tubing.No other abnormalities were observed.Functional and pressure testing confirmed drops of water to be flowing out of the location of the hole in the silicone segment.The cause of the leak was due to the small hole in the pump segment silicone tubing near the upper fitment.The root cause of the hole could not be determined.
Event or Problem Description
It was reported the rn noticed a hole on the pump segment near the upper fitment of the iv tubing that caused a leak.It is unknown if this event occurred during infusion or priming.The customer provided a photo of the tubing.Although requested, there is no additional patient or event information available.

• 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: 9087215
• Report Number: 9616066-2019-02624
• Device Sequence Number: 19464773
• Product Code: FPA
• UDI-Device Identifier: 10885403234224
• UDI-Public: 10885403234224
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: C24103E
• Device Catalogue Number: C24103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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: 100ML BAXTER BAG,ALCOHOL CAPS, TD 4/3/19