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

Model Number	MX9968
Medical Device Problem Codes	Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.Patient demographics requested however not provided.
Event or Problem Description
It was reported that the user was administering a normal saline bolus simultaneously administering a unspecified pain medication when a leak was observed.Upon closer observation the user noticed a slit in the tubing.
Additional Manufacturer Narrative
Product grid revised to not sequested.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the user was administering a normal saline bolus simultaneously administering a unspecified pain medication when a leak was observed.Upon closer observation the user noticed a slit/hole in the tubing proximal to patient, past second port.The customer stated that there was no patient harm.

• 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: 8773089
• Report Number: 9616066-2019-01881
• Device Sequence Number: 16654834
• Product Code: FPA
• UDI-Device Identifier: 10885403237805
• UDI-Public: 10885403237805
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: MX9968
• Device Catalogue Number: MX9968
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1