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

Model Number	10015612
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 8110, 8015, bd 60 ml syringe; icu medical microclave, model and lot unknown.Therapy date (b)(6) 2018.Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the affected product be received for evaluation.
Event or Problem Description
The customer reported that during a calcium chloride infusion, a leak was discovered with the last 10-15 ml of the infusion between the needleless valve and the psd tubing.The rate was under 5 ml/hr.The clinician obtained a new syringe and tubing to continue the patient¿s infusion.No patient harm was reported.
Event or Problem Description
The customer reported that during a calcium chloride (1 gm/50 ml dextrose 5% for a final concentration of 0.02 gm/ml) infusion, a leak was discovered with the last 10-15 ml of the infusion between the needleless valve and the psd tubing.The rate was under 5 ml/hr.The clinician obtained a new syringe and tubing to continue the patient¿s infusion.No patient harm was reported.
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Additional Manufacturer Narrative
The customer¿s report of a leak was confirmed; however, the leak originated from the non-bd microclave valve and not from the connection between the microclave and extension set as reported.Functional testing was conducted on the bd set.The set primed successfully with no leaks or other anomalies observed.During pressure testing leaking was noted from the microclave itself with no leaking at the connection between the microclave and extension set.The female luer port of the bd set was measured and found to be within iso standards.The root cause of the leak was the non-bd microclave.
Event or Problem Description
The customer reported that during an infusion of calcium chloride (1 gm/50 ml dextrose 5%, final concentration of 0.02 gm/ml), a leak was discovered with the last 10-15 ml of the infusion between the needleless valve and the pressure sensing disc tubing.The rate was less than 5 ml/hr.The clinician obtained a new syringe and tubing to continue the patient¿s infusion.No patient harm was reported.

• Brand Name: ALARIS® SYRINGE MODULE SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7866785
• Report Number: 9616066-2018-01601
• Device Sequence Number: 1950794
• Product Code: FPA
• UDI-Device Identifier: 10885403234040
• UDI-Public: 10885403234040
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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,Followup
• Report Date (Section B): 08/17/2018

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: 10015612
• Device Catalogue Number: 10015612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 10/10/2018; 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR