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

Model Number	2425-0500
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "patient began with continuous chemo at 1145 at 5ml/hr.Line flushed and blood return noted prior to chemo start.At 12:15 rate increased to 10 ml/hr.Twenty mins later, chemo paused secondary to patient calling out and saying his "bed feels wet and i haven't peed".Rn noted tubing felt wet and was leaking at lower y-site closest to the patient.Chemo disconnected and new tubing primed.Doctor to bedside at this time.Decided to do a 25ml replacement bag by chemo rn, aprn & md which will be hung at the end of this remaining bag." the event occurred in the patient's room.An incomplete date of event of (b)(6) 2018 was provided.
Additional Manufacturer Narrative
Non bd spike adapter; non bd spiros adapter.The customer¿s report that the tube leaked chemotherapy at the y-site was confirmed to be a leak from the distal smartsite port near the distal male luer.Functional testing observed a leak at the distal smartsite port.Closer inspection under magnification noted a small hole in the blue piston of the smartsite located near one of the ends of the middle slit.The cause of the customer¿s report is a small hole in the smartsite blue piston.The root cause of the piston damage/puncture is a manufacturing issue.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "patient began with continuous chemo at 1145 at 5ml/hr.Line flushed and blood return noted prior to chemo start.At 12:15 rate increased to 10 ml/hr.Twenty mins later, chemo paused secondary to patient calling out and saying his "bed feels wet and i haven't peed".Rn noted tubing felt wet and was leaking at lower y-site closest to the patient.Chemo disconnected and new tubing primed.Doctor to bedside at this time.Decided to do a 25ml replacement bag by chemo rn, aprn & md which will be hung at the end of this remaining bag." the event occurred in the patient's room and there was no patient harm.

• 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: 8467102
• Report Number: 9616066-2019-00866
• Device Sequence Number: 19580656
• Product Code: FPA
• UDI-Device Identifier: 07613203021395
• UDI-Public: 7613203021395
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K951922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2425-0500
• Device Catalogue Number: 2425-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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: GREEN SWAB CAP
• Outcome Attributed to Adverse Event: Required Intervention