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

Model Number	10927766
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Type of Reportable Event	Malfunction
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
It was reported that when administering electrolytes, infusion set pull apart at the pump segment.The nurse switch out the tubing which causes delay.There was no harm to patient.
Additional Manufacturer Narrative
Correction; h.6.(patient code).The customer¿s report that the infusion set pull apart at the pump segment was confirmed.Functional testing could not be performed due to the set's separation and receiving only a partial set.Visual inspection confirmed that the separation occurs between the silicone pump segment tubing and the upper fitment.The set was received separated at the top of the pumping segment.The ring retainer was not received with the set and a ring retainer indentation was observed around the end of the silicone pump tubing where the separation occurs, indicating that it had been assembled onto the set.The root cause could not be definitively determined.
Event or Problem Description
It was reported that when administering electrolytes, the infusion set pulls apart at the pump segment.The rn switch out the tubing which caused a delay.Although requested, there has been no further patient or event information made available to date.

• 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: 9321496
• Report Number: 9616066-2019-03268
• Device Sequence Number: 2374138
• Product Code: FPA
• UDI-Device Identifier: 07613203019101
• UDI-Public: 7613203019101
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 10/23/2019

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: 08/02/2022
• Device Model Number: 10927766
• Device Catalogue Number: 10927766
• Device Lot Number: 19085130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR