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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/60" (152 CM) APPX 2.2 ML, SMALLBORE EXT SET W/CHEMOLOCK PORT, CL CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/60" (152 CM) APPX 2.2 ML, SMALLBORE EXT SET W/CHEMOLOCK PORT, CL CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Catalog Number CL3960
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/14/2020
Event Type  malfunction  
Manufacturer Narrative
The device is not available for investigation. Without the return of the device a probable cause is unable to be determined. If additional information becomes available a supplemental report will be submitted. A device history review (dhr) could not be completed due to the unknown lot number.
 
Event Description
The customer reported a smallbore ext set w/chemolock port and cadd line that filled with air during the patient¿s infusion and shutting off the pump. The extension set was primed with saline and the air was distal to the pump and distal to the filter. The pump did not audibly alarm for the air in line and the clinician did not see the air. The patient did not get any air and the air did not pass the cassette. It was unknown if stopcocks or extension tubing was used. The pump and tubing set was replaced. It was unknown if the pump and tubing set was tested together. There was patient involvement but no delay in therapy or human harm reported. This is the first of two events reported.
 
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Brand NameONCOLOGY KIT W/60" (152 CM) APPX 2.2 ML, SMALLBORE EXT SET W/CHEMOLOCK PORT, CL
Type of DeviceCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
ensenada, b.cfa. 22790
MX 22790
Manufacturer Contact
michael visocnik
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key10521911
MDR Text Key213063667
Report Number9617594-2020-00378
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131549
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCL3960
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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