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

Model Number	11426964
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
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 devices be received for evaluation.Device return expected.
Event or Problem Description
The reported feedback suggests that the failure of safety clamp fitment activation on removing set from lvp channel post use.
Additional Manufacturer Narrative
A 11426964 sample was received for investigation with residual fluid throughout; no packaging was received with the sample, however the customer indicates the affected lot number to be 19075574.Additionally an empty 100ml baxter nacl iv bag was received connected to the spike component to assist the investigation.A visual inspection did not identify any signs of damage or manufacturing defects which could have contributed to the customer's experience.Functional testing was performed by placing the set into an alaris system lvp module from bd stock and continuously opening and closing the pump door; in each instance the flow stop was noted to be correctly activated.The samples were then subjected to pressure testing while the flow stop was occluded; no fluid flow was noted to move beyond the flow stop in each instance.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 19075574 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.It was not possible to confirm the root cause of the reported issue in this instance.Testing of the returned sample did not identify any product defects or quality deviations that could have contributed to the customer¿s experience.H3 other text : see section h.10.
Event or Problem Description
The reported feedback suggests that the failure of safety clamp fitment activation on removing set from lvp channel post use.

• 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: 9489702
• Report Number: 9616066-2019-03697
• Device Sequence Number: 296802
• Product Code: FPA
• UDI-Device Identifier: 10885403232367
• UDI-Public: 10885403232367
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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 Expiration Date: 07/06/2022
• Device Model Number: 11426964
• Device Catalogue Number: 11426964
• Device Lot Number: 19075574
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1