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

Model Number	10821753
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
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.The customer stated that the patient was a pediatric patient.
Event or Problem Description
It was reported that the burette separated and leaked from the tubing set where the spike enters the top of the burette when the nurse moved the iv from the stretcher to an iv pole.The tubing set was quickly replaced.The customer further stated that there were no adverse effects caused to the pediatric patient from the event.
Event or Problem Description
It was reported that the burette separated and leaked from the tubing set where the spike enters the top of the burette when the nurse moved the iv from the stretcher to an iv pole.The tubing set was quickly replaced.The customer further stated that there were no adverse effects caused to the pediatric patient from the event.
Additional Manufacturer Narrative
The customer¿s report that the burette separated and leaked from the tubing set where the spike enters the top of the burette was confirmed.Visual inspection of the set noted separation at the engagement between the filter outlet and tubing sleeve.Closer inspection of the separation under magnification observed insufficient solvent at the engagement.No functional testing was performed due to the separation.The separated tubing end was also measured to be within specification.The root cause was identified as due to insufficient solvent being applied at the engagement of the tubing.

• 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: 8908047
• Report Number: 9616066-2019-02337
• Device Sequence Number: 19515732
• Product Code: FPA
• UDI-Device Identifier: 07613203019187
• UDI-Public: 7613203019187
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 07/30/2019

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: 10821753
• Device Catalogue Number: 10821753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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: 8015, 8100, THERAPY DATE (B)(6) 2019