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

Model Number	24009-0007T
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was received unexpectedly with an unknown issue.Inspection of the set sample observed a slight bulge along the silicone segment component.Further handling observed bulge area noted felt weaker as compared to the rest of the silicone segment.Further inspection noted no issues with its concentricity as well as no issues with its dimension specifications.Previous extensive failure investigation concluded that a bulge in tubing can occur when an iv push medication or flush is executed below the pump without first clamping the tubing above the injection port resulting in excessive pressure within the silicone segment.Clinical advice for an iv push medication or flush is to be executed below the pump and clamping the tubing above the injection port.Pressure testing observed that the silicone segment area directly below the upper fitment component started to bulge around 15psi.Further pressure was ceased as the set is rated to withstand pressure up to 30psi with no observed issues.The bulge is caused by excessive pressure within the silicone segment.The root cause for the source of the excessive pressure is unknown.
Event or Problem Description
Product was received unexpectedly with an unknown issue.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8822882
• Report Number: 9616066-2019-02049
• Device Sequence Number: 14267410
• Product Code: FPA
• UDI-Device Identifier: 10885403273827
• UDI-Public: 10885403273827
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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: 24009-0007T
• Device Catalogue Number: 24009-0007T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1