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

Model Number	10813621
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer declined to return the product for failure investigation.The root cause of this failure was not identified.Although requested, no additional patient information provided.
Event or Problem Description
It was reported that the stopcocks ¿are backwards¿.It was observed that "these are no tab for off and short tabs for on." the clinician states that "unless you turn off the stopcock after setting it up, you¿ll get splashed with blood/fluid/etc., when you take off the white port cap." it was reported that there was no user or patient harm.The event did not result in a delay that significantly impacted patient outcome.
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint of misassembly backward stopcock could not be confirmed due to the product was not returned for failure investigation.Photo of the partial set with the stopcock provided by the customer showed the set was assembled.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the stopcocks; ¿are backwards¿.It was observed that; "these are no tab for off and short tabs for on".The clinician states that; "unless you turn off the stopcock after setting it up, you¿ll get splashed with blood/fluid/etc., when you take off the white port cap".It was further reported that there was no user or patient harm as a result of this event.The event did not result in a delay that significantly impacted patient outcome.

• 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: 9580867
• Report Number: 9616066-2020-00120
• Device Sequence Number: 595723
• Product Code: FPA
• UDI-Device Identifier: 10885403234514
• UDI-Public: 10885403234514
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/23/2019

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: 10813621
• Device Catalogue Number: 10813621
• 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: 01/13/2020
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1