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

Model Number	10010570
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.The event reportedly occurred in the nicu; therefore it is presumed the patient was a neonate: race: w.Initials: (b)(6).Observed on though white patient information sticker attached to the note received with sample, unknown if initials was for mother of baby or (b)(6) initials.
Event or Problem Description
Product received unexpectedly, there was a note attached with the returned product that stated; medication line difficult to flush, when administrating iv push ativan the user noticed that the 1.2 micron filter leaked, wasting all of the ativan dose.It was reported by the rn that prior to administrating the iv push medication, the roller clamps were deactivated.The note attached to the patient information sticker stated that the event occurred in nicu.Although several attempts made for event details from product received there was no response from the customer.
Additional Manufacturer Narrative
The customer¿s report of a filter leak during an iv push was confirmed.Visual inspection observed dried fluid residue within the filter component.No other issues were observed.Functional testing was performed; fluid was observed to leak out from the set's filter weld.The cause of the leak is an issue with the weld line of the filter component.The root cause of the weld line issue is a supplier manufacturing issue of the filter component.
Event or Problem Description
Product received unexpectedly , there was a note attached with the returned product that stated; medication line difficult to flush, when administrating iv push ativan the user noticed that the 1.2 micron filter leaked, wasting all of the ativan dose.It was reported by the rn that prior to administrating the iv push medication, the roller clamps were deactivated.The note attached to the patient information sticker stated that the event occurred in nicu.Although several attempts made for event details from product received there was no response from the customer.

• Brand Name: ALARIS® EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8283709
• Report Number: 9616066-2019-00183
• Device Sequence Number: 11089430
• Product Code: FPA
• UDI-Device Identifier: 10885403233500
• UDI-Public: 10885403233500
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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: 10010570
• Device Catalogue Number: 10010570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 03/26/2019
• 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: MICROCLAVE ,THERAPY DATE (B)(6) 2018
• Patient Age: 11 MO