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U.S. Department of Health and Human Services

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

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CAREFUSION MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameMAXZERO NEEDLELESS CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8741831
MDR Text Key149506766
Report Number9616066-2019-01788
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2019 Patient Sequence Number: 1
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