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

Model Number 20128E

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hypoglycemia (1912)

Event Date 07/13/2018

Event Type  Injury  

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.

Event Description

The customer reported that during an infusion, the patient's blood sugar was low due to a leak in the "lipid filter." the nurse was getting ready to hang a higher concentration of dextrose solution when she noticed a leak.Once the filter was changed, the baby¿s blood sugar returned to normal levels.There was no report of lasting harm.

Manufacturer Narrative

The customer¿s report of a leak in the filter was confirmed and replicated.Visual inspection including microscopic exam revealed no holes/tears in the filter membrane or damage to the filter housing.Functional and pressure testing was performed; a leak was observed at the filter vent closest to the output port.The root cause was identified as the fluid resistance of the filter becoming roughly equivalent to the fluid resistance of the air vent after becoming clogged from prolonged exposure, increasing backpressure at which time the fluid seeks the path of least resistance through the filter vent.

Event Description

The customer reported that during an infusion, the patient's blood sugar was low due to a leak in the "lipid filter." the nurse was getting ready to hang a higher concentration of dextrose solution when she noticed a leak.Once the filter was changed, the baby¿s blood sugar returned to normal levels.There was no report of lasting harm.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7773633
• MDR Text Key: 116787942
• Report Number: 9616066-2018-01270
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203011839
• UDI-Public: 7613203011839
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2021
• Device Model Number: 20128E
• Device Catalogue Number: 20128E
• Device Lot Number: 18045338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other