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

Model Number	11607704
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 500ml braun bag, lot: j9l190, exp: 03/22, 0.9% sodium chloride injection.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 iv tubing spike broke off in iv bag when rn attempted to spike the iv bag.There was no patient harm.Although requested, patient demographics were not provided.
Additional Manufacturer Narrative
Section; b.5.(event description - patient/event information clarified).************************************************************************** the customer¿s report that the tubing spike broke off in iv bag was confirmed based on inspection it was observed that the drip chamber spike tip was broken off with the broken off spike tip piece lodged within the infusion bag port.The infusion bag port was not pierced fully.Further inspection of the damaged spike surface observed the breakage to be rough and uneven.The infusion bag's port opening was observed to very firm and rigid with minimal flexibility.This may have facilitated the observed breakage.Visual inspection observed the spike tip of the drip chamber was broken off and the broken off spike tip.No other obvious damage or issue was observed.The root cause of the external lateral force was not identified.
Event or Problem Description
It was reported that the iv tubing spike broke off in the iv bag when the nurse attempted to spike the iv bag.It was further confirmed during follow up, that there was no patient harm or impact as a result of this event.Patient demographics were requested but not provided.

• 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: 9668126
• Report Number: 9616066-2020-00234
• Device Sequence Number: 16927788
• 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,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: 11607704
• Device Catalogue Number: 11607704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/20/2020
• 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: THERAPY DATE: (B)(6) 2020.