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

Model Number	2478-0000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.The customer stated that the product expiration date, lot number or manufacturer date is unavailable.
Event or Problem Description
It was reported that the blood tubing set separated from the drip chamber prior to spiking the bag or in use on a patient.The tubing set was not pulled on or forced in any way to cause the tubing to separate from the drip chamber.The customer further stated that there were no adverse effects caused to the patient or staff member as there were no fluid/medication in the tubing set when it separated and the event occurred prior to patient use, therefore, there was no patient involvement.
Additional Manufacturer Narrative
The customer¿s report that the blood tubing set separated from the drip chamber was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection observed that the pvc tubing on one of the two spikes is completely separated from the blood filter¿s top inlet port.Closer inspection of the separation under a lab microscope observed that the tubing had no solvent applied at engagement during manufacturing process.No other anomalies or damages were observed.Dimensional analysis was performed and the tubing was measured and observed to be within specification(s).Functional testing was not necessary as it is obvious that a leak would occur as a result of the separation.The root cause that the blood tubing set separated from the drip chamber was a manufacturing issue.
Event or Problem Description
It was reported that the blood tubing set separated from the drip chamber prior to spiking the bag or in use on a patient.The tubing set was not pulled on or forced in any way to cause the tubing to separate from the drip chamber.The customer further stated that there were no adverse effects caused to the patient or staff member as there were no fluid/medication in the tubing set when it separated as the event occurred prior to patient use, therefore; there was no patient involvement.

• 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: 9347310
• Report Number: 9616066-2019-03365
• Device Sequence Number: 2734752
• Product Code: FPA
• UDI-Device Identifier: 10885403235122
• UDI-Public: 10885403235122
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• 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): 10/31/2019

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: 2478-0000
• Device Catalogue Number: 2478-0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1