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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP PLUMSET 2CLAVES-SL SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL COSTA RICA LTD. NDEHP PLUMSET 2CLAVES-SL SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 1468728
Device Problems Loss of or Failure to Bond (1068); Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
Manufacturer Narrative
The returned set was visually inspected and no anomalies were evident. The set was air pressure leak tested per product specifications and a leak was found at the outlet port, however, no tubing damage was found. The tubing od was measured and found to be within specification. The tubing was pulled from the socket, examined and evidence of incomplete solvent bond coverage was found. The complaint can be confirmed, the probable cause of the leak can be attributed to a bonding error. A device history review (dhr) could not be conducted because no lot number(s) was/were identified.
 
Event Description
It was reported that, on an unknown date, the nurse was having issues with the plumset involved in the event. The device is alleged to have a crack to the cassette at the insertion of the proximal tubing. The report states, the patient reported dripping from the pump during a milirone infusion and called the nurse into the room. There was a reported delay in treatment due to the need for a new bag of medication to be prepared and tubing replacement. There was no harm to the patient reported.
 
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Brand NameNDEHP PLUMSET 2CLAVES-SL
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL COSTA RICA LTD.
zona franca global
la aurora heredia
CS
Manufacturer Contact
michael visocnik
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key12139143
MDR Text Key261241300
Report Number9615050-2021-00092
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1468728
Device Catalogue Number146870489
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
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

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