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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION ALARIS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 20028E
Device Problem Contamination (1120)
Patient Problems Venipuncture (2129); No Consequences Or Impact To Patient (2199)
Event Date 07/15/2019
Event Type  Injury  
Manufacturer Narrative
Blood cultures drawn, results were not received.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
It was reported that the tpn filter was contaminated by the purulent drainage from an open jackson pratt drain to the patient's right buttock.The infectious disease md was notified, and the picc line was removed and replaced with a new iv.Blood cultures were drawn.A staff member also noted that the brown drainage in the filter was from a different jp drain.There was no patient harm reported.
 
Event Description
It was reported that the tpn filter was contaminated by the purulent drainage from an open jackson pratt drain to the patient's right buttock.The infectious disease md was notified, and the picc line was removed and replaced with a new iv.Blood cultures were drawn.A staff member also noted that the brown drainage in the filter was from a different jp drain.There was no patient harm reported.
 
Manufacturer Narrative
The customer¿s report of the tpn filter was contaminated by the purulent drainage from an open jackson pratt drain was confirmed.Visual inspection of the set noted a brownish liquid was inside the set¿s 0.2 micron filter.Examination under magnification observed a slight tear in the membrane of the filter at the location of the filter vent closest to the filter¿s intake section.Clear liquid was observed in the set¿s tubing.No other abnormalities were observed.Functional and pressure testing confirmed leaking out of filter vent closest to the filter¿s intake section.The cause of the contaminate entering the filter was identified as a slight tear in the membrane of the set¿s filter at the location of the filter vent closest to the filter¿s intake section.The root cause of the damage to the membrane is unknown.
 
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Brand Name
ALARIS EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8889973
MDR Text Key154184398
Report Number9616066-2019-02299
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012393
UDI-Public7613203012393
Combination Product (y/n)N
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 07/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20028E
Device Catalogue Number20028E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
2420-0500,10ML BD SYRINGE, TD 7/15/19; DARK BLUE DUALCAP DISINFECTING CAP; 2420-0500,10ML BD SYRINGE, TD (B)(6) 2019
Patient Outcome(s) Other;
Patient Age64 YR
Patient Weight57
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