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

Model Number	11607704
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 1000 ml baxter bag; non bd extension set; 100 ml wg critical bag, therapy date unk.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
Event or Problem Description
It was reported that the unit manager was answering a call light and was assisting the patient to the bathroom when the alaris lvp detached from the pcu and fell causing the tubing set to separate during a magnesium/0.9% sodium chloride infusion.
Additional Manufacturer Narrative
Disregard initial file suspect has been changed from a disposable set to an instrument.Please reference the new manufacturer #2016493-2019-00690 from emdr (b)(4).
Event or Problem Description
It was reported that the unit manager answered a call light on the medical/surgical unit to assist the adult patient to the bathroom and while crossing over the bathroom door threshold the alaris pump module detached from the pcu and fell to the floor causing the tubing set to separate and leak at the upper fitment during a primary infusion of 0.9% sodium chloride and a secondary infusion of magnesium/0.9% sodium chloride infusion.It was later stated that facility biomed presumes that the pump module was not fully latched/connected to the pcu.Due to this the customer would like bd to consider adding a safety feature that warns when the pump module is not fully attached to the pcu.The customer also stated that there were no adverse effects caused to the patient from the event.

• 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: 8664966
• Report Number: 9616066-2019-01504
• Device Sequence Number: 2340641
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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: 11607704
• Device Catalogue Number: 11607704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/03/2019
• 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: 8100,8015, THERAPY DATE UNK