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 Separation (1562)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
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, however, the customer stated that the patient was a neonatal patient.Additional patient information: clabsi - developed positive blood cultures 48 hour after the event.
Event or Problem Description
It was reported that the tubing set was in use on a neonatal patient in the nicu, when the bedside nurse noted leaking from the tubing set at the point of connection to the upper fitment.When the tubing was removed and disconnected from the patient, the connection of the tubing and the upper fitment was checked by lightly pulling on the tubing which caused the tubing set to easily separate from the upper fitment.The customer later stated that the neonate patient had a positive blood culture within 48 hours of the event (clabsi) requiring antibiotics.
Additional Manufacturer Narrative
The customer¿s report that the tubing set separated from the upper fitment was confirmed.The set was visually inspected for obvious damage such as incomplete bonding engagements, cracks, kinks, holes, and tears in the tubing and its components.During visual inspection of the as-received set, it was observed immediately that the silicone segment was partially separated from the upper fitment at the pump segment.Functional testing was not performed due to a leak that would occur from the separated tubing.Photo evidence of the set completely separated was also provided from the customer.No crush marks were observed on the upper or lower fitment.The silicone pump tubing was found to be within measurement specification(s).The root cause of the separation was not definitively identified.
Event or Problem Description
It was reported that the tubing set was in use on a neonatal patient in the nicu, when the bedside nurse noted leaking from the tubing set at the point of connection to the upper fitment.When the tubing was removed and disconnected from the patient, the connection of the tubing and the upper fitment was checked by lightly pulling on the tubing which caused the tubing set to easily separate from the upper fitment.The customer later stated that the neonate patient had a positive blood culture within 48 hours of the event (clabsi) requiring antibiotics.

• 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: 9276463
• Report Number: 9616066-2019-03081
• Device Sequence Number: 11308520
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: 2200-0500
• Device Catalogue Number: 2200-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 11/14/2019
• 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; 8100, 8015, TD (B)(6) 2019
• Outcome Attributed to Adverse Event: Required Intervention