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

Model Number	2232-0007
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.The event occurred at a childrens hospital, therefore it is presumed that the patient was either an child, infant or neonate.
Event or Problem Description
It was reported that the normal saline infusion kept backing up during the epinephrine, norepinephrine and normal saline flush infusions which prevented accurate and timely delivery of the necessary medications.The tubing set was changed to a non-filtered tubing set and the medications infused without further difficulty.
Event or Problem Description
It was reported that the normal saline infusion kept backing up during the epinephrine, norepinephrine and normal saline flush infusions which prevented accurate and timely delivery of the necessary medications.The tubing set was changed to a non-filtered tubing set and the medications infused without further difficulty.Although requested, there is no additional patient or event information available.
Additional Manufacturer Narrative
The customers report that the infusion kept backing up was not confirmed.The as-received set sample was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components no obvious damages or issues were observed during visual inspection.The set was attempted to be re-primed; no issues were observed.Further testing was performed by attaching a lab gauge needle to the male luer of the reprimed set and the set was loaded into a lab pump module.An infusion was programmed to run at a rate of 10ml for one hour.The infusion completed with no issues or any alarms.The set was also pressure tested and no issues were observed.The root cause that the infusion kept backing up was unable to be identified.

• 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: 9121087
• Report Number: 9616066-2019-02649
• Device Sequence Number: 3587159
• Product Code: FPA
• UDI-Device Identifier: 10885403463969
• UDI-Public: 10885403463969
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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: 2232-0007
• Device Catalogue Number: 2232-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 12/04/2019
• 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: (3) 8100, (2) PRI TUBING, 8015, TD (B)(6) 2019