MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,ADMINISTRAITON,INTRAVASCULAR

Model Number	ME2064
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: double lumen picc; bifuse tubing set;non-bd used microclave;used bd 5ml syringe; td (b)(6) 2019.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Additional patient information: infant; race: w.
Event or Problem Description
It was reported that the infant patient had a double lumen picc line that was located in the left femoral artery.The picc's first lumen had the following infusions; milrinone infusing at a rate of 1.8ml/hour, dopamine at a rate of 2ml/hour, versed at a rate of 0.4ml/hour, morphine at a rate of 0.5ml/hour and cis at a rate of 1.4ml/hour infusing.The second picc line lumen had an extension tubing set attached to a heparin locked bi-fuse tubing set.This medication line was used to administer the scheduled 8:00 pm medications of lasix and phenobarbital when the filter broke.
Event or Problem Description
It was reported that the infant patient had a double lumen picc line that was located in the left femoral artery.The picc's first lumen had the following infusions; milrinone infusing at a rate of 1.8ml/hour, dopamine at a rate of 2ml/hour, versed at a rate of 0.4ml/hour, morphine at a rate of 0.5ml/hour and cis at a rate of 1.4ml/hour infusing.The second picc line lumen had an extension tubing set attached to a heparin locked bi-fuse tubing set.This medication line was used to administer the scheduled 8:00 pm medications of lasix and phenobarbital when the filter broke.
Additional Manufacturer Narrative
Patient demographic a.4 was requested, however not received.The customer¿s report that the filter broke was confirmed.During visual inspection clear liquid was observed inside the set¿s tubing and 0.2 micron gamma ped filter.During functional testing small droplet leaked from the 0.2 micron gamma ped filter¿s weld line nearest to the filter¿s inlet port, confirming the customer¿s report.Pressure testing confirmed the leak.The root cause of the weld line leak is due to a supplier manufacturing error by the supplier.

• Brand Name: EXTENSION SET
• Common Device Name: SET,ADMINISTRAITON,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8786633
• Report Number: 9616066-2019-01909
• Device Sequence Number: 16643965
• Product Code: FPA
• UDI-Device Identifier: 10885403236280
• UDI-Public: 10885403236280
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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: ME2064
• Device Catalogue Number: ME2064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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, TD (B)(6) 2019
• Patient Age: 10 MO