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	Low Blood Pressure/ Hypotension (1914)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 an epinephrine infusion, a leak occurred between the needleless valve and the psd tubing with the last 10-15 ml of the infusion.The event was discovered when the patient¿s blood pressure dropped unexpectedly.The rate was under 5 ml/hr.The md was notified and a new medication was ordered in a new syringe.The patient¿s blood pressure stabilized with no lasting effects of the event reported.
Event or Problem Description
The customer reported that during an epinephrine infusion (3 mg in 50 ml dextrose 5% for a final concentration of 0.06 mg/ml), a leak occurred between the needleless valve and the psd tubing with the last 10-15 ml of the infusion.The event was discovered when the patient¿s blood pressure dropped unexpectedly.The rate was under 5 ml/hr.The md was notified and a new medication was ordered in a new syringe.The patient¿s blood pressure stabilized with no lasting effects of the event reported.
Additional Manufacturer Narrative
The customer¿s report of a tubing leak was not confirmed.Visual inspection (including microscopic) observed no anomalies with the returned extension set.Functional and pressure testing was performed; no leaks were observed during the testing.The syringe set's male luer and female luer were dimensionally tested; the returned sample was within specification.The root cause of the reported tubing leak was not identified.

• 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: 7873187
• Report Number: 9616066-2018-01599
• Device Sequence Number: 1986012
• 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
• 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?: Yes
• 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
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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,MICROCLAVE, TD (B)(6) 2018; 8110,8015, SYRINGE,MICROCLAVE, TD (B)(6) 2018
• Outcome Attributed to Adverse Event: Other
• Patient Age: 2 YR