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

Model Number MZ1000-07

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problems Low Blood Pressure/ Hypotension (1914); Therapeutic Response, Decreased (2271); No Code Available (3191)

Event Date 06/16/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: central venous line; picc line.Therapy date (b)(6) 2018.No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.(b)(4).

Event Description

The customer reported that the patient had a picc line and right internal jugular central venous line (rij cvl) that experienced occlusions and leaks.The picc line was noted to be leaking and required rewirement causing the nurse to suspect that the patient was not receiving the ordered inotropes.The picc lumen stopped working and the infusions of epinephrine at 0.03, calcium, milrinone, dexamethasone and fentanyl were switched to a different lumen with the occluded lumen eventually requiring administration of tpa.The patient experienced decreased pressures and required an increase in sedation boluses.It was later noted that the picc line presented with sluggish blood return with the pumps alarming occlusion/high pressure.The maxzero¿ valves were removed from the infusion lines and the issue was resolved.The rij cvl required re-suturing and rewiring due to leaking and had no further issues after the rewiring; however, it was later reported that the rij cvl required tpa due to sluggish blood return while continuing to flush easily.Heparin was infusing at a kvo rate to keep the line open.The rij cvl continued to leak with dressing changes and skin excoriation noted under the dressing and eventually was discontinued due to the leaking and excoriation.The customer alleges that the maxzero¿ valve was not working correctly and was causing the line occlusions and leaks.There was no report of lasting harm caused to the patient.Based on information currently available, the reported leaks appear to all be around the catheter insertion site(s) with no apparent leaking from a bd product.

Event Description

The customer reported that the patient had a picc line and right internal jugular central venous line (rij cvl) that experienced occlusions and leaks.The picc line was noted to be leaking and required rewirement causing the nurse to suspect that the patient was not receiving the ordered inotropes.The picc lumen stopped working and the infusions of epinephrine at 0.03, calcium, milrinone, dexamethasone and fentanyl were switched to a different lumen with the occluded lumen eventually requiring administration of tpa.The patient experienced decreased pressures and required an increase in sedation boluses.It was later noted that the picc line presented with sluggish blood return with the pumps alarming occlusion/high pressure.The maxzero valves were removed from the infusion lines and the issue was resolved.The rij cvl required re-suturing and rewiring due to leaking and had no further issues after the rewiring, however, it was later reported that the rij cvl required tpa due to sluggish blood return while continuing to flush easily.Heparin was infusing at a kvo rate to keep the line open.The rij cvl continued to leak with dressing changes and skin excoriation noted under the dressing and eventually was discontinued due to the leaking and excoriation.The customer alleges that the maxzero valve was not working correctly and was causing the line occlusions and leaks.There was no report of lasting harm caused to the patient.Based on information currently available, the reported leaks appear to all be around the catheter insertion site(s) with no apparent leaking from a bd product.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7881086
• MDR Text Key: 120416203
• Report Number: 9616066-2018-01692
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230196
• UDI-Public: 10885403230196
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

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 Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (9) MZ9267,(6) MZ1000-07, SYRINGE, TD (B)(6) 2018; (9) MZ9267,(6) MZ1000-07, SYRINGE, TD (B)(6) 2018
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 2 MO
• Patient Weight: 3