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

Model Number	11607704
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Although requested, additional information was not provided.
Event or Problem Description
The customer received the iv tubing set from staff with no information, and reported that there was an unspecified iv tubing set issue.When the product was sent to bd for investigation and received, it was then noted that the tubing set had a tear and was labeled "cracked." the tubing set also was labeled "amio" which is most likely an amiodarone infusion.There was no report of consequence or impact to a patient from any event involving the product.No further information was provided.
Additional Manufacturer Narrative
The customer returned product with an unspecified iv tubing issue.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection noted a small tubing tear on the tubing 25.5 inches above the primary set¿s distal smartsite.The tear site was jagged and uneven and was measured to be 0.003 inches in length.No other damages, tool marks, or anomalies were observed.Functional testing confirmed leaking from the tubing tear.A device history record could not be performed due to no lot number was provided by the customer.The root cause of the tear could not be determined.
Event or Problem Description
The customer received the iv tubing set from staff with no information, and reported that there was an unspecified iv tubing set issue.When the product was sent to bd for investigation and received, it was then noted that the tubing set had a tear and was labeled "cracked." the tubing set also was labeled "amio" which is most likely an amiodarone infusion.There was no report of consequence or impact to a patient from any event involving the product.No further information was provided.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMIN, INTRAVASCULAR.
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10158278
• Report Number: 9616066-2020-01918
• Device Sequence Number: 16968965
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

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: 06/02/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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: (3)CUROS CAPS, TD UNKNOWN