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

Model Number	2452-0007
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2019
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 during a saline infusion on a cardiac patient, the iv tubing separated at the top of the silicone segment and iv fluid leaked onto the floor.No patient harm occurred.New tubing was obtained to continue the patient's infusion.
Event or Problem Description
It was reported that during a saline infusion on a cardiac patient, the iv tubing separated at the top of the silicone segment and iv fluid leaked onto the floor.No patient harm occurred.New tubing was obtained to continue the patient's infusion.
Additional Manufacturer Narrative
The customer¿s report that the iv tubing separated at the top of the silicone segment and iv fluid leaked was confirmed.During visual inspection it was noted that the tubing was torn at the proximal end of silicone tubing and the portion of the silicone tubing where the ring retainer is seated was not returned for investigation.The surface of the damaged tubing site was jagged and uneven.Remnants of clear liquid was observed inside the set¿s tubing throughout the as-received set.Functional testing was not necessary as it is obvious that a leak would occur from this separation.The root cause of the torn tubing was due to external force applied at the silicone tubing that was stretched beyond specification.

• 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: 8848875
• Report Number: 9616066-2019-02145
• Device Sequence Number: 242843
• Product Code: FPA
• UDI-Device Identifier: 10885403219870
• UDI-Public: 10885403219870
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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: 2452-0007
• Device Catalogue Number: 2452-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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: 8100, 8015, TD (B)(6) 2019