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

Model Number	2426-0500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the product be received for evaluation.
Event or Problem Description
The customer reported that the surgery department is having issues with the tubing exploding when administrating lr and diprovan while on a patient.There was no patient harm.
Event or Problem Description
The customer reported that the anesthesia department is having issues with the tubing separating and leaking at the drip chamber outlet port junction when administrating diprovan ivp.There was no patient harm.
Additional Manufacturer Narrative
The customer¿s report of tubing broke ¿separated¿ and leaked was confirmed.Visual inspection of the set noted that the pvc tubing was completely separated from the drip chamber outlet port.Examination under magnification noted that both sides of the pvc tubing had no solvent applied at the engagement.There were no other anomalies observed.Functional testing was deemed unnecessary due to tubing being separated at the component engagement.Fluid was leaking from the separation.Dimensional analysis was performed and the vinyl tubing was measured to be within specification.The root cause of the customer¿s report was identified as a manufacturing issue due to no solvent being applied at the junction of the vinyl tubing.
Event or Problem Description
The customer reported that the surgery department is having issues with the tubing breaking and leaking when administrating lr and diprovan while on a patient.There was no patient harm.
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
The customer reported that the anesthesia department is having issues with the tubing breaking and leaking when administrating lr or diprovan while on a patient.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: 7956281
• Report Number: 9616066-2018-01907
• Device Sequence Number: 428313
• Product Code: FPA
• UDI-Device Identifier: 10885403235689
• UDI-Public: 10885403235689
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/19/2018

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: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 17103145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 10/11/2018
• Supplement Report FDA Received Date: 10/22/2018; 10/29/2018; 12/10/2018
• 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: NON-BD EXT SET, THERAPY DATE UNK