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	09/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: (4) 8110.8015.(3) 10015612.(4) syringe.(4) icu medical microclave needleless connector.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 four sets leaked at the connection to a different manufacturer's needleless connector during a patient's infusion.The four infusions (epinephrine, milrinone, arterial line, cvp line) were started during the evening of (b)(6) 2018 on the night shift to run into a sterile container until the time for the tubing change.Early in the morning on (b)(6) 2018, the new tubing ¿tree¿ (iv pole with pc unit and attached pump modules) was connected to the patient and the old ¿tree¿ was removed.There was no report of a leak at this time.The patient¿s blood pressure started to decline the morning of (b)(6) 2018 despite dose adjustments.The epinephrine tubing was wet between the microclave and the tubing, and wetness was observed further down the tubing.Upon inspection, the user discovered that the milrinone, arterial line and cvp lines were also damp at the connections to the needleless connectors, indicating leaks.After the leaks were discovered, the tubing was changed and the patient¿s blood pressure subsequently stabilized with no other effects to the patient reported.
Event or Problem Description
The customer reported that four sets leaked at the connection to a different manufacturer's needleless connector during a patient's infusion.The four infusions (epinephrine, milrinone, arterial line, cvp line) were started during the evening of (b)(6) 2018 on the night shift to run into a sterile container until the time for the tubing change.Early in the morning on (b)(6) 2018, the new tubing ¿tree¿ (iv pole with pc unit and attached pump modules) was connected to the patient and the old ¿tree¿ was removed.There was no report of a leak at this time.The patient¿s blood pressure started to decline the morning of (b)(6) 2018 despite dose adjustments.The epinephrine tubing was wet between the microclave and the tubing, and wetness was observed further down the tubing.Upon inspection, the user discovered that the milrinone, arterial line and cvp lines were also damp at the connections to the needleless connectors, indicating leaks.After the leaks were discovered, the tubing was changed and the patient¿s blood pressure subsequently stabilized with no other effects to the patient reported.
Additional Manufacturer Narrative
The customer¿s report that four sets leaked at the connection to a non-bd needleless connector was confirmed; however, the leak originated from the non-bd microclave valve itself and not from the connection between the valve and the bd extension set.During functional testing, fluid leaked from the non-bd valve.No leaks were noted with the bd set or the connection between the valve and the set.The female luer port of the bd extension set was measured and found to be within iso standards.The root cause of the leak is the non-bd product.

• 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: 7975657
• Report Number: 9616066-2018-01902
• Device Sequence Number: 16516073
• 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): 09/19/2018

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: 10/23/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other