MAUDE Adverse Event Report: CAREFUSION NON-VENTED GRAVITY BLOOD SET

Model Number	42081E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.(b)(4).
Event or Problem Description
The customer reported that the micron filter in the gravity non-vented blood set collapsed when administrating blood quickly with a unspecified syringe.The event occurred in the ct (cardiothoracic) or.Received a copy of the customer's medsun report from the fda which states "the filter on the carefusion gravity blood tubing 42081e collapses when using a syringe method to quickly administer blood during cardiac surgery.And the drip chamber is difficult to fill causing air to get into the line if administering blood emergently¿.
Event or Problem Description
The customer reported that the micron filter in the gravity non-vented blood set collapsed when administrating blood quickly with a unspecified syringe.The event occurred in the ct (cardiothoracic) or.Although requested, no additional information about the patient, or event provided.Received a copy of the customer's medsun report from the fda which states "the filter on the carefusion gravity blood tubing 42081e collapses when using a syringe method to quickly administer blood during cardiac surgery.And the drip chamber is difficult to fill causing air to get into the line if administering blood emergently¿.

• Brand Name: NON-VENTED GRAVITY BLOOD SET
• Common Device Name: BLOOD SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7887823
• Report Number: 9616066-2018-01712
• Device Sequence Number: 228216
• Product Code: FPA
• UDI-Device Identifier: 07613203020855
• UDI-Public: 7613203020855
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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: 42081E
• Device Catalogue Number: 42081E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 09/21/2018
• 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: SYRINGE, THERAPY DATE (B)(6) 2018