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

Model Number	4030B-07T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that during a chemotherapy infusion of cisplatin 110mg/500 ml mannitol/ ns at 500ml/hr over 1 hour, the set separated from the cisplatin bag and leaked.There was no harm.
Additional Manufacturer Narrative
(disregard (b)(4)).The customer¿s report that the set separated from the infusion bag and leaked was not confirmed.However, a separation was confirmed between the tubing and filter outlet.Visual inspection of the set noted separation at the engagement between the filter outlet and tubing sleeve.Closer inspection of the separation under magnification observed insufficient solvent at the engagement.No functional testing was performed due to the separation.The tubing sleeve¿s outer diameter was measured and found to be within specification.The root cause of the separation is due to insufficient solvent.
Event or Problem Description
It was reported that during a chemotherapy cisplatin 110mg/500 ml mannitol/ ns at 500ml/hr over 1 hour, the set separated from the cisplatin bag and leaked.There was no harm.

• Brand Name: ALARIS GRAVITY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8845916
• Report Number: 9616066-2019-02095
• Device Sequence Number: 2548863
• Product Code: FPA
• UDI-Device Identifier: 10885403278358
• UDI-Public: 10885403278358
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 4030B-07T
• Device Catalogue Number: 4030B-07T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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: 10012241-0500,500 ML BAXTER BAG, TD (B)(6) 2019; 10012241-0500,500 ML BAXTER BAG, TD (B)(6) 2019
• Patient Weight: 76