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 (filled to 50 ml); icu medical microclave; 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 heparin infusion, the 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.
Event or Problem Description
The customer reported that during a heparin (50 units in 50 ml sodium chloride 0.9%) intraarterial infusion, the 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 customer¿s report of a leak was not confirmed.Visual inspection observed no anomalies.Functional and pressured testing was performed.No issues were observed.The root cause of the reported failure was not identified.
Event or Problem Description
The customer reported that during a heparin (50 units in 50 ml sodium chloride 0.9%) intraarterial infusion, the leak was discovered with the last 10-15 ml of the infusion between the needleless valve and the psd tubing.The rate was under 1 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: 7866820
• Report Number: 9616066-2018-01600
• Device Sequence Number: 13883168
• 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; 12/19/2018
• 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