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

Model Number	2200-0500
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
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.Patient age and dob requested but not provided.
Event or Problem Description
It was reported that the iv tubing set had a hole in the bottom portion of the silicone segment that caused approximately one-half of the zosyn antibiotic iv fluids to leak.It was noted that the tubing set had been in use prior to this infusion without difficulty.A new antibiotic iv solution was obtained from the pharmacy and a new tubing set was used.
Event or Problem Description
It was reported that the iv tubing set had a hole in the bottom portion of the silicone segment that caused approximately one-half of the zosyn antibiotic iv fluids to leak during use on an adult patient.It was noted that the tubing set had been in use prior to this infusion without difficulty.A new antibiotic iv solution was obtained from the pharmacy and a new tubing set was used and the patient successfully received the medication.The customer states that there was no harm caused to the patient from the event.
Additional Manufacturer Narrative
The customer¿s report of tubing set with hole in silicone segment that leaked was confirmed.Visual inspection of the set received it was observed immediately that the silicone segment had a pin hole near the lower fitment.Visual examination under microscope noted no crush marks to the upper or lower blue fitment.No other anomalies were noted during visual inspection.Functional testing was performed by attaching the set to a bag filled with tap water and allowing fluid to flow through the set via gravity.A leak was immediately observed coming out from the silicone tubing near the lower fitment.The root cause of the pin hole could not be definitively determined,.

• 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: 8489508
• Report Number: 9616066-2019-00906
• Device Sequence Number: 11233746
• Product Code: FPA
• UDI-Device Identifier: 07613203012638
• UDI-Public: 7613203012638
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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
• Report Date (Section B): 03/13/2019

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: 2200-0500
• Device Catalogue Number: 2200-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 07/15/2019
• 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: 8015, 8100, TD (B)(6) 2019