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

Model Number	10012144
Medical Device Problem Codes	Break (1069); Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
It was reported that the event occurred in the operating room when the md anesthesiologist attempted to put a 20 ml syringe into the middle of the needleless port.The syringe was pushed back off of the needleless port, half of the port cracked/broke off, and the fluid was pouring out of the site.The lactated ringer's solution (lr) were infusing at the time of the event.The tubing was quickly changed and the medication was continued for the patient.There was no patient harm.
Event or Problem Description
It was reported that the event occurred in the operating room when the md anesthesiologist attempted to put a 20 ml syringe onto middle needleless port.The syringe was pushed back off of the needleless port, half of the port cracked/broke off, and the fluid was pouring out of the site.The lactated ringer's solution (lr) were infusing at the time of the event.The tubing was quickly changed and the medication was continued for the patient.There was no patient harm.
Additional Manufacturer Narrative
Additional information provided: the customer¿s report that the needless port cracked and/or broke off was confirmed.Visual inspection noted the primary set¿s distal smartsite female luer adapted was broken in half at an angle.Closer inspection observed white stress marks at the break site with rough and uneven surfaces.The broken off piece of the smartsite¿s fla was not received.No other visual anomalies were observed.Functional testing could not be conducted due to the break on the smartsite.The probable root cause of the smartsite break is excessive force being applied to the smartsite as indicated by the observed stress marks.Additionally, extended exposure to alcohol in disinfecting caps could weaken the plastic of the smartsite making it easier to break.The root cause of the breakage could not be definitively determined.

• 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: 8935847
• Report Number: 9616066-2019-02409
• Device Sequence Number: 449968
• Product Code: FPA
• UDI-Device Identifier: 07613203021159
• UDI-Public: 7613203021159
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/05/2019

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: 10012144
• Device Catalogue Number: 10012144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/07/2019
• 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: BD 20ML SYRINGE, THERAPY DATE (B)(6) 2019; BD 20ML SYRINGE, THERAPY DATE (B)(6) 2019
• Patient Age: 27 YR
• Patient Weight: 86