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

Model Number	MZ9325
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2020
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.Premature infant.
Event or Problem Description
It was reported that during an infusion in the specialty care nursery; a new trifuse was set up at 2200 and a leak was identified in the isolette at 0445.The rn flushed the trifuse with normal saline syringe to find a hole in the lipid filter while administering a tpn/lipids 20% infusion with vtbi of 8ml for a duration of 6hr.The trifuse was attached to a premature infant, birth weight (b)(6), with 32 completed weeks of gestation.This was discovered after noticing the bed under the infant was wet.The infant was not receiving lipids as intended, therefore; the trifuse was removed and a new trifuse placed.There was no patient impact.
Event or Problem Description
It was reported that during an infusion in the specialty care nursery; a new trifuse was set up at 2200 and a leak was identified in the isolette at 0445.The nurse flushed the trifuse with a normal saline syringe to find a hole in the lipid filter while administering a tpn/lipids 20% infusion with vtbi of 8ml for a duration of 6hr.The trifuse was attached to a premature infant, birth weight 12500-1499 grams, with 32 completed weeks of gestation.This was discovered after noticing the bed under the infant was wet.The infant was not receiving lipids as intended, therefore; the trifuse was removed and a new trifuse placed.Although it was noted that there was a delay in treatment, it was also confirmed during follow up, that there was no patient harm or impact as a result of this event.
Additional Manufacturer Narrative
The customer's report that the tubing leaked at the filter was confirmed.The set was inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection of the set's 0.2 micron ped filter's air vent membrane was wetted/compromised and functional testing observed a leak (termed ¿weeping out¿) from the same area.No other obvious issues or damages were observed.The root cause of the leak was unable to be identified.

• Brand Name: MAXZERO EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9613352
• Report Number: 9616066-2020-00219
• Device Sequence Number: 19437227
• Product Code: FPA
• UDI-Device Identifier: 10885403427244
• UDI-Public: 10885403427244
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MZ9325
• Device Catalogue Number: MZ9325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 03/19/2020
• 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: 10ML BD SYRINGE, THERAPY DATE: (B)(6) 2020.
• Patient Age: 21 DA
• Patient Weight: 1