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

Model Number	2232-0007
Medical Device Problem Codes	Backflow (1064); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
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.Patient demographics requested but not provided.
Event or Problem Description
It was reported from the ics that when the nurse disconnected the tubing set from the patient's peripheral iv, the end of the tubing set became "stuck" in the "clave" and the patient's blood began to backup into the line.The tubing set connector and "clave" were changed.The customer later stated that there were no adverse effects caused to the patient from the event.
Event or Problem Description
It was reported from the (ics that when the nurse disconnected the tubing set from the patient's peripheral iv, the end of the tubing set became "stuck" in the "clave", and the patient's blood began to back-up into the line.The tubing set connector and "clave" were changed.The customer later stated that there were no adverse effects caused to the child patient from this event.
Additional Manufacturer Narrative
The customer¿s report that the tubing set became "stuck" in the "clave" (extension set¿s microclave) and that blood backed up into the line was confirmed.The sets were visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection observed that the model's male luer tip piece was broken off and lodged inside the female port of the extension set¿s microclave.Closer inspection under a lab microscope observed that the break sites¿ surfaces showed signs of stress marks and had jagged and uneven edges.Residual blood was also observed within the tubing of the extension set.No other anomalies or damages were observed.It was concluded that an excessive external lateral/leverage force was applied to the primary set¿s male luer when disconnecting from the extension set, thus causing it to break.Functional testing could not be performed due to the breakage of model 2232-0007¿s male luer tip lodged inside the extension set¿s microclave female luer.The breakage was caused by an external lateral force.The root cause was not identified.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9476939
• Report Number: 9616066-2019-03573
• Device Sequence Number: 14101536
• 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: K931173
• 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): 11/19/2019

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: 12/06/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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: 8015, 8100, TD (B)(6) 2019; NON-BD EXTENSION SET