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

Model Number	10373772
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
It was reported that a line pressure alarm read -2, the rn noted a large amount of blood in bed.The line was clamped and inspected, however a crack and leakage was noted in the extension set at the distal end.The extension set was replaced and the status of the patient was continuously monitored and found to be stable.
Additional Manufacturer Narrative
The customer¿s report that a line pressure alarmed and a crack and leakage was noted in the extension set at the distal end was confirmed.Visual inspection observed a lateral crack in the female luer wall located at the top end of the female luer opposite of the luer gate.Inspection also observed a lateral crack in the male luer¿s spin collar.Functional testing observed that the source of the leak is due to a crack in the female luer component.The root cause of the female luer crack was identified to be a result of internal stresses created during the manufacturing process that make it more susceptible to chemical/mechanical attacks and the pvc materials used in the new female luer.
Event or Problem Description
It was reported that there was a crack on the distal end of the extension tubing set.The arterial line pressure alarm read -2 when connected to a neonate and the nurse noted a large amount of blood on the patient's bed.The line was clamped and the extension set was replaced.The patient required close monitoring after status checked and was found to be stable.Additional monitoring prevented further adverse effects.
Event or Problem Description
It was reported that there was a crack on the distal end of the extension tubing set.The arterial line pressure alarm read -2 when connected to a neonate and the nurse noted a large amount of blood on the patient's bed.The line was clamped and the extension set was replaced.The neonate patient was status/post open heart surgery and required close monitoring after status checked and was found to be stable.Additional monitoring prevented further adverse effects.

• Brand Name: EXTENSION SET
• Common Device Name: SET,EXTENSION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9730982
• Report Number: 9616066-2020-00510
• Device Sequence Number: 18924039
• Product Code: FPA
• UDI-Device Identifier: 10885403234194
• UDI-Public: 10885403234194
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2020

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: 10373772
• Device Catalogue Number: 10373772
• Device Lot Number: 18075294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/27/2020; 05/12/2020
• 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: 8110, 8015,SYRINGE, TD UNK
• Outcome Attributed to Adverse Event: Required Intervention