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

Model Number MZ1000-07

Device Problems Obstruction of Flow (2423); Improper Flow or Infusion (2954)

Patient Problems Venipuncture (2129); Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

Although requested, no patient demographics were supplied except a nicu infant, (b)(6) week gestation at birth.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that an occlusion occurred for an infant receiving tpn and lipids at low rates via two different pumps and a peripherally inserted central catheter (picc line).The pumps alarmed for occlusion, and user troubleshooting determined that the picc was occluded.After troubleshooting, patency was not restored and the picc line was removed and replaced.No other effect to the infant was reported.The patient's infusion set up was a 1.2 french picc line attached to the needleless connector which was attached to the bifuse which had two needleless connectors at the extension ends.The event reporter did not have exact details, and stated typically the extensions had tpn (typically 7-10 ml/hr) and lipids (typically 0.4 to 0.5 ml/hr) infusing.Clinicians utilize chlorhexidine to cleanse needleless connection points prior to attaching the tubing or flushing.The nurse educator stated that occlusions had occurred four times with four different infants.This file is for one event.She also stated that occlusions had not reoccurred after changing the procedure whereby the needleless connector attached directly to the picc line was removed and the bifuse male luer was connected directly to the hub of the picc line.

Manufacturer Narrative

The customer¿s report of occluded picc line resulted in picc line removal and replacement could not be confirmed due to the product not returned for failure investigation.Although a photo was provided by the customer, the location of the occlusion could not be determined and the customer complaint of occlusion was not confirmed.The root cause of this failure was not identified as no product was returned.

Event Description

It was reported that an occlusion occurred for an infant receiving tpn and lipids at low rates via two different pumps and a peripherally inserted central catheter (picc line).The pumps alarmed for occlusion, and user troubleshooting determined that the picc was occluded.After troubleshooting, patency was not restored and the picc line was removed and replaced.No other effect to the infant was reported.The patient's infusion set up was a 1.2 french picc line attached to the needleless connector which was attached to the bifuse which had two needleless connectors at the extension ends.The event reporter did not have exact details, and stated typically the extensions had tpn (typically 7-10 ml/hr) and lipids (typically 0.4 to 0.5 ml/hr) infusing.Clinicians utilize chlorhexidine to cleanse needleless connection points prior to attaching the tubing or flushing.The nurse educator stated that occlusions had occurred four times with four different infants.This file is for one event.She also stated that occlusions had not reoccurred after changing the procedure whereby the needleless connector attached directly to the picc line was removed and the bifuse male luer was connected directly to the hub of the picc line.

Event Description

It was reported that an occlusion occurred for an infant receiving tpn and lipids at low rates via two different pumps and a peripherally inserted central catheter (picc line).The pumps alarmed for occlusion, and user troubleshooting determined that the picc was occluded.After troubleshooting, patency was not restored and the picc line was removed and replaced.No other effect to the infant was reported.The patient's infusion set up was a 1.2 french picc line attached to the needleless connector which was attached to the bifuse which had two needleless connectors at the extension ends.The event reporter did not have exact details, and stated typically the extensions had tpn (typically 7-10 ml/hr) and lipids (typically 0.4 to 0.5 ml/hr) infusing.Clinicians utilize chlorhexidine to cleanse needleless connection points prior to attaching the tubing or flushing.The nurse educator stated that occlusions had occurred four times with four different infants.This file is for one event.She also stated that occlusions had not reoccurred after changing the procedure whereby the needleless connector attached directly to the picc line was removed and the bifuse male luer was connected directly to the hub of the picc line.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8814454
• MDR Text Key: 151920473
• Report Number: 9616066-2019-01988
• Device Sequence Number: 1
• Product Code: FPA
• 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,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MZ9265,8100,8015,THERAPY DATE: UNKNOWN