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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD MAXPLUS POSITIVE PRESSURE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET
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CAREFUSION SD MAXPLUS POSITIVE PRESSURE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MP1000 CHINA
Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Device Contamination with Chemical or Other Material (2944)
Patient Problem Injury (2348)
Event Date 08/18/2020
Event Type  Injury  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that maxplus positive pressure connector was damaged and had foreign matter.The following information was provided by the initial reporter: on the afternoon of (b)(6) 2020, the nurse found that the blue rubber plug of the infusion connector (mp1000) was slightly damaged during the regular flushing of the picc tube (the connector was replaced on the morning of (b)(6)).The front end of the picc catheter disc was similar.The blue suspicious substance, the withdrawal catheter is unobstructed, but the blue suspicious substance in the catheter cannot be extracted or moved.The infusion connector will be replaced to continue the infusion.After the shift in the morning of (b)(6), the nurse found that the picc catheter was blocked.The suspicious blue substance on the tip of the catheter disc was gone.The child had no abnormal symptoms.Reported to the nursing team leader and the doctor in charge immediately to remove the picc catheter as instructed.After removing the catheter, a blue rubber plug with a infusion connector was found on the catheter disc.
 
Manufacturer Narrative
A mp1000 china sample was not available for investigation of this feedback; however from the information provided by the customer it appears that part of the piston of the maxzero had become damaged and dislodged during connection with a picc, and that this resulted in the catheter becoming occluded.No further information or photographs were provided to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 16028087 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined in this instance.Without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the reported issue.In this instance, without the complaint sample or additional information about the exact nature of the defect it is not possible to conclusively link this feedback to a specific failure mode.
 
Event Description
It was reported that maxplus positive pressure connector was damaged and had foreign matter.The following information was provided by the initial reporter: on the afternoon of (b)(6) 2020, the nurse found that the blue rubber plug of the infusion connector (mp1000) was slightly damaged during the regular flushing of the picc tube (the connector was replaced on the morning of (b)(6)).The front end of the picc catheter disc was similar.The blue suspicious substance, the withdrawal catheter is unobstructed, but the blue suspicious substance in the catheter cannot be extracted or moved.The infusion connector will be replaced to continue the infusion.After the shift in the morning of (b)(6), the nurse found that the picc catheter was blocked.The suspicious blue substance on the tip of the catheter disc was gone.The child had no abnormal symptoms.Reported to the nursing team leader and the doctor in charge immediately to remove the picc catheter as instructed.After removing the catheter, a blue rubber plug with a infusion connector was found on the catheter disc.
 
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Brand Name
MAXPLUS POSITIVE PRESSURE CONNECTOR
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key10587631
MDR Text Key208570712
Report Number9616066-2020-02794
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K072542
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/26/2021
Device Model NumberMP1000 CHINA
Device Catalogue NumberMP1000 CHINA
Device Lot Number16028087
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
20200818; 20200818; 20200818
Patient Outcome(s) Other;
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