MAUDE Adverse Event Report: CAREFUSION NON-VENTED BLOOD SET

Model Number	2478-0000
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
System service line account manager.Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
Event or Problem Description
The customer reported that in the pacu/operating room, the set was primed with saline using one of the set's spikes, when the other side of the y-tubing, (which had not yet spiked the blood), came off.This occurred while the set was attached to the patient, and saline spilled.Contradicting information was reported by stating there was no patient harm, and also stating it was "unknown at this time".Contradicting information was reported, stating this was a "near miss (did not reach the patient)", and stating in another portion of the report the tubing was connected to the patient.Patient harm was not reported.
Additional Manufacturer Narrative
The customer¿s report of tubing separated was confirmed.Visual inspection of the set noted that pvc tubing was completely separated from the drip chamber blood filter top cap inlet port.Examination under magnification noted that both sides of the pvc tubing had insufficient solvent applied at the engagement.There were no other anomalies observed.Functional testing was deemed unnecessary due to tubing being separated at the component engagement.Dimensional analysis was performed and the tubing measured to be within specification.The root cause was due to insufficient solvent being applied at the engagement of the tubing during manufacturing process.
Event or Problem Description
The customer reported that in the pacu/operating room, the set was primed with saline using one of the set's spikes, when the other side of the y-tubing, (which had not yet spiked the blood), came off.This occurred while the set was attached to the patient, and saline spilled.Patient harm was not reported.

• Brand Name: NON-VENTED BLOOD SET
• Common Device Name: BLOOD SET
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7896145
• Report Number: 9616066-2018-01768
• Device Sequence Number: 14040226
• Product Code: FPA
• UDI-Device Identifier: 10885403235122
• UDI-Public: 10885403235122
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K894842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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 Expiration Date: 05/30/2021
• Device Model Number: 2478-0000
• Device Catalogue Number: 2478-0000
• Device Lot Number: 18055459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 02/04/2019
• 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: 8100,8015, THERAPY DATE (B)(6) 2018
• Patient Age: 74 YR