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

Model Number MZ1000-07

Device Problems Partial Blockage (1065); Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: picc line (1.9 french); event occurred may, 2019.Specific date not available.(b)(4).The affected product has been received and the investigation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Although requested, patient demographic details and laboratory/test details and pre-existing medical conditions were not provided.The patient is an infant.

Event Description

It was reported that an occlusion occurred in the nicu 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.Tpa was administered to restore patency.Patency continued until the following day when the line occluded again and the picc line was removed and replaced.No other effect to the infant was reported.The patient's infusion set up was a 1.9 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 ml/hr) infusing.The connector on the patient's picc line was not sequestered, however the bifuse set was saved.Clinicians utilize chlorhexidine to cleanse needleless connection points prior to attaching the tubing or flushing.The nurse educator stated that occlusions had occurred with four patients.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 connected directly to the hub of the picc line.

Manufacturer Narrative

The customer¿s report of an occlusion was not confirmed.Visual inspection of the concomitant set noted no damage or any anomalies.Functional and pressure testing resulted in the set flowing freely and showed no signs of occlusion from each port.The root cause of the customer¿s report of occlusion was not identified.The suspect max-zero set was not returned for investigation.

Event Description

It was reported that an occlusion occurred in the nicu 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.Tpa was administered to restore patency.Patency continued until the following day when the line occluded again and the picc line was removed and replaced.No other effect to the infant was reported.The patient's infusion set up was a 1.9 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 ml/hr) infusing.The connector on the patient's picc line was not sequestered, however the bifuse set was saved.Clinicians utilize chlorhexidine to cleanse needleless connection points prior to attaching the tubing or flushing.The nurse educator stated that occlusions had occurred with four patients.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 connected directly to the hub of the picc line.

• 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: 8741831
• MDR Text Key: 149506766
• Report Number: 9616066-2019-01788
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403240775
• UDI-Public: 10885403240775
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/30/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,MZ1000,PRI TUBING,8015, TD UNK; MZ9265
• Patient Outcome(s): Required Intervention