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

Model Number	C25004E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Anemia (1706); Blood Loss (2597)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that an anemic icu patient requiring multiple transfusions was transferred to radiology for an mri procedure.The patient was transported with a long and short extension set primed with heparin (50/units/ml /25,000u/ 500ml) at an unspecified rate, while the infusion devices remained outside the mri suite.Within 30 minutes of connection to the extension sets, blood backed up the line and leaked onto the floor, creating an approximately 30 inch pool of blood.It was subsequently reported that the patient later required a unit of blood that same day; possibly from the volume of blood loss from the event.Although requested, no further details or information was provided regarding this event, and no information was received as to the recovery of the patient.
Event or Problem Description
It was reported that an anemic icu patient requiring multiple transfusions was transferred to radiology for an mri procedure.The patient was transported with a long and short extension set primed with heparin (50/units/ml /25,000u/ 500ml) at an unspecified rate, while the infusion devices remained outside the mri suite.Within 30 minutes of connection to the extension sets, blood backed up the line and leaked onto the floor; creating an approximately 30 inch pool of blood.It was subsequently reported that the patient later required a unit of blood that same day; possibly from the volume of blood loss from the event.Although requested, no further details or information was provided regarding this event, and no information was received as to the recovery of the patient.
Additional Manufacturer Narrative
The customer¿s report that blood backed up the line and leaked was confirmed.Visual inspection of set found a crack in the female luer wall on the opposite end of the injection gate of the filter extension set.The location of the luer gate on the female luer (below the ¿wings¿) indicates that this female luer was manufactured after the change order that moved the injection gate to a lower location to help mitigate and prevent female luer cracks.No tool marks or signs of over torque were observed.Functional testing confirmed leaking from the cracked female luer.The source of the blood backing up and leaking is due to a crack found on the female luer.The root cause of the female luer crack could not be determined.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8416790
• Report Number: 9616066-2019-00663
• Device Sequence Number: 239732
• Product Code: FPA
• UDI-Device Identifier: 10885403235580
• UDI-Public: 10885403235580
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C25004E
• Device Catalogue Number: C25004E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/10/2019
• 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,(2)3026E,10012144, TD 2/113/19; 8015, 8100, (2) 3026E,10012144, TD (B)(6) 2019
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 22 YR