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

Model Number MZ9283

Device Problem Fluid/Blood Leak (1250)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

The customer reported that the tubing leaked epinephrine around the fused cap of the set, which caused the patient to become hypotensive; then when the tubing was changed the patient became hypertensive while the set was connected to the patient's central line.The sedation was held since it was initially thought to be the cause of the hypotension however it was later determined that the hypotension was due to the lack of epinephrine caused by the leak.There was no lasting harm.

Manufacturer Narrative

The customer¿s report of a leak was confirmed.Functional testing confirmed leaking from two ports on the first quadfuse set, one port of the second quadfuse set, and one port of the third quadfuse set.Examination under magnification showed a microchannel on the interior walls of the maxzero component which allowed fluid to leak.Each maxzero port was measured and found to be within specification.The root cause of the microchannel is an equipment error during the inspection and testing process during final assembly of the maxzero component.

Event Description

The customer reported that the tubing leaked epinephrine around the fused cap of the set, which caused the patient to become hypotensive; then when the tubing was changed the patient became hypertensive while the set was connected to the patient's central line.The sedation was held since it was initially thought to be the cause of the hypotension however it was later determined that the hypotension was due to the lack of epinephrine caused by the leak.There was no lasting harm.

Event Description

The customer reported that the tubing leaked epinephrine around the fused cap of the set, which caused the patient to become hypotensive; then when the tubing was changed the patient became hypertensive while the set was connected to the patient's central line.The sedation was held since it was initially thought to be the cause of the hypotension however it was later determined that the hypotension was due to the lack of epinephrine caused by the leak.There was no lasting harm.

• Brand Name: MINIBORE EXTENSION SET
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7685810
• MDR Text Key: 113908301
• Report Number: 9616066-2018-00984
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230608
• UDI-Public: 10885403230608
• Combination Product (y/n): N
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2021
• Device Model Number: MZ9283
• Device Catalogue Number: MZ9283
• Device Lot Number: 18015671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (3)MZ9283, CENTRAL LINE, THERAPY DATE: (B)(6) 2018; MZ5307; (3)MZ9283, CENTRAL LINE, THERAPY DATE: (B)(6) 2018
• Patient Outcome(s): Other; Required Intervention