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

Model Number	2426-0007
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Although requested, patient demographics were not provided.
Event or Problem Description
It was reported from (b)(6) center that the tubing had separated from the safety clamp.There were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
The customer¿s report that the tubing had separated from the safety clamp was confirmed to be a separation between the silicone segment and lower fitment.During visual inspection it was observed that the silicone segment was separated from the lower fitment at the pump segment.The ring retainer was not received with the set and a ring retainer indentation was not observed around the separated end of the silicone tubing segment.Functional testing could not be performed due to the separation and obvious leaking that would occur.The root cause of the silicone segment separation was identified as a manufacturing issue for the set¿s ring retainer not assembled onto the set during the assembly process due to cleaning procedures of the equipment and operator error.
Event or Problem Description
It was reported from the first hill campus of the swedish cancer institute treatment center that the tubing had separated from the safety clamp.There were no adverse effects caused to the patient from the event.
Event or Problem Description
It was reported from the first hill campus of the swedish cancer institute treatment center that the tubing had separated from the safety clamp.There were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
Correction: g5;d4.Additional info: d11.

• 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: 10136453
• Report Number: 9616066-2020-01885
• Device Sequence Number: 1848449
• Product Code: FPA
• UDI-Device Identifier: 10885403232268
• UDI-Public: 10885403232268
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2020

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: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/22/2020; 08/12/2020
• 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: 8015,8100, TD 01/01/2020; EQUASHIELD SYRINGE ADAPTOR, TD 01/01/2020; 8015, 8100, TD (B)(6) 2020