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

Model Number	2429-0007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
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 the outpatient surgery that the tip of the tubing broke off while spiking the bag of iv fluid.There was no patient involvement.
Additional Manufacturer Narrative
The customer's report that the tip of the tubing broke off was confirmed.The drip chamber's spike tip was broken off.The broken off spike tip piece was not received for evaluation.Further inspection of the damaged spike surface observed the breakage to be rough and uneven.The nature of the breakage indicates a ductile fracture (vs.A brittle fracture) that is typically caused by an external impulse/impact force.No testing was deemed necessary due to the obvious breakage.The breakage was caused by an external lateral force.The root cause of the external lateral force was not identified.The device history record search for set model 2429-0007 lot 20015593 shows the set was manufactured on 07jan2020 with a total of (b)(4) units.There were no quality notifications issued during the production build of this set.
Event or Problem Description
It was reported from the outpatient surgery that the tip of the tubing broke off while spiking the bag of iv fluid.There was no patient involvement.

• 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: 9961187
• Report Number: 9616066-2020-01338
• Device Sequence Number: 16829413
• Product Code: FPA
• UDI-Device Identifier: 10885403220890
• UDI-Public: 10885403220890
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/30/2020

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 Expiration Date: 01/07/2023
• Device Model Number: 2429-0007
• Device Catalogue Number: 2429-0007
• Device Lot Number: 20015593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1