MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXZERO¿ ZERO REFLUX IV CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZ1000-07

Device Problems Fracture (1260); Leak/Splash (1354)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported while using maxzero¿ zero reflux iv connector the device was cracked.This is report 1 of 6.There was no report of patient impact.The following information was provided by the initial reporter: issue #1: cracked connector.Date of awareness: 9/27/2023.Occurred over the weekend.It happened twice.One was a picc line, one was a femoral line.The only thing being infused was fluids on one and blood on the other.One of these patients ended up getting a clabsi.

Manufacturer Narrative

Awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint that there was a leak could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

No new information received.Material#: mz1000-07, batch number: unknown.It was reported by customer that account: iu (b)(6).Product: max zero mz1000-07.Issue #1: cracked connector, date of awareness 9/27/2023, occurred over the weekend.It happened twice.One was a picc line, one was a femoral line.The only thing being infused was fluids on one and blood on the other.One of these patients ended up getting a clabsi.Issue #2: leaking at the catheter hub to max zero connection.Date of awareness 9/27/2023.This occurred a couple times.One time the patient had a double lumen tunneled line and was getting iv fluids.There was a valve guard, which is essentially a dressing that goes over the connector and hub of the iv and protects from fluids like vomit and feces.The nurse noticed an accumulation of fluid in the valveguard and observed leaking at the hub of the catheter where it connects to the max zero connector.This was an established line, not a brand new line.Their practice is to visually observe lines every 12 hours and leaking had not been observed prior to.This patient had a positive blood culture.Samples are being sent issue #3: blood backing up.Date of awareness 9/27/2023.This has occurred multiple times with multiple different types of lines.They said while the line is in use and infusing, they have observed blood backing up into the connector.This observation has caused concern for many of the clinicians.This is mostly occurring or being reported on piccs and tunneled lines but not on pivs.They are not using a stopcock here, they only use stopcocks to draw blood.On their crrt they have observed blood backing up.We discussed the high pressures in crrt and the max pressure for max zero.If the connector is engaged and the pressure is high it will allow fluid to flow to the area of least resistance.Issue #4: disconnected infusion.Date of awareness: 9/27/2023.The patient was getting iv fluids infused.This was an established line, not a new line.It is there policy to observe lines every 12 hours.The patient was receiving an infusion and the tubing just popped off.This occurred one time.Issue #5: tpn filter broke off.Date of awareness: 9/27/2023.Tnp filter is luer connected to max zero.It snapped off (clearly on the tnp filter side) not at the luer lock.Blood leaked out of the patient due to the connector being engaged the tpn filter broken.Sample is being sent.

• Brand Name: MAXZERO¿ ZERO REFLUX IV CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17925508
• MDR Text Key: 325591760
• Report Number: 9616066-2023-02063
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ1000-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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