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

Model Number	2200-0500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 from unit horvitz 4 that the nurse was spiking a bag of d10/normal saline 0.25 when the tubing set spike broke off.Although there was a delay in medication therapy in order for a new iv bag to be prepared, there were no adverse effects caused to the patient from the event.
Event or Problem Description
It was reported from unit horvitz 4 that the nurse was spiking a bag of d10/normal saline 0.25 when the tubing set spike broke off.Although there was a delay in medication therapy in order for a new iv bag to be prepared, there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
The customer¿s report that the tubing set spike broke off was confirmed.Visual inspection observed that the drip chamber spike tip was broken off.The drip chamber spike tip was not received with the set.Closer inspection of the crack under a lab microscope did not see any evidence of tool marks or scratch marks.Functional testing was not performed due to the crack at the drip chamber spike base.The crack breakage was caused by an external impulse/impact force.The root cause of the external impulse/impact force was not identified.

• 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: 9725650
• Report Number: 9616066-2020-00457
• Device Sequence Number: 2139845
• Product Code: FPA
• UDI-Device Identifier: 07613203012638
• UDI-Public: 7613203012638
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: 2200-0500
• Device Catalogue Number: 2200-0500
• Device Lot Number: 19117320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/07/2020
• 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: NON-BD EXTENSION SET, TD (B)(6) 2020