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

Model Number	PRI TUBING
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Insufficient Flow or Under Infusion (2182); Failure to Deliver (2338)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.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 physician had difficulty assembling the anesthesia set due to the components were incompatible; "the male luer connector at the end of an extension tube did not open the valve on the female y-port".The customer stated that the trauma patient had a delay in critical medications due to the issue however the staff was able to connect the set after fixing the issue.It was later reported turns out to be a compatibility issue with icu medical¿s male luer lock being unable to engage the smart site y-port on bd¿s tubing sets.The physician was able to quickly determine the incompatibility and change the method of delivery.
Additional Manufacturer Narrative
Correction: d.4.
Event or Problem Description
It was reported that the physician had difficulty assembling the anesthesia set due to the components were incompatible; "the male luer connector at the end of an extension tube did not open the valve on the female y-port".The customer stated that the trauma patient had a delay in critical medications due to the issue however the staff was able to connect the set after fixing the issue.It was later reported turns out to be a compatibility issue with icu medical¿s male luer lock being unable to engage the smart site y-port on bd¿s tubing sets.The physician was able to quickly determine the incompatibility and change the method of delivery.

• 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: 9221375
• Report Number: 9616066-2019-02955
• Device Sequence Number: 2157399
• Product Code: FPA
• UDI-Device Identifier: 10885403232497
• UDI-Public: 10885403232497
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 09/27/2019

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: PRI TUBING
• Device Catalogue Number: PRI TUBING
• 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: 10/22/2019
• Supplement Report FDA Received Date: 12/06/2019
• 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 SET,ICU MEDICAL MALE LUER, TD (B)(6) 2019