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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD LIFESHIELD PRIMARY PLUMSET CLAVEPORT, CLAVE Y-SITE 103 INCH, NON-DEHP ADMINISTRATION SET

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ICU MEDICAL COSTA RICA LTD LIFESHIELD PRIMARY PLUMSET CLAVEPORT, CLAVE Y-SITE 103 INCH, NON-DEHP ADMINISTRATION SET Back to Search Results
Model Number N/A
Device Problem Disconnection (1171)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888)
Event Date 11/15/2018
Event Type  Death  
Manufacturer Narrative
The actual device involved in the event is not available for testing and investigation. However, the facility has a sister sample available for testing. It has not yet been received.
 
Event Description
The customer contact confirmed the primary plum tubing set was attached to the right internal jugular central line, which was infusing normal saline at a keep vein open rate. The nurse administered 2mg morphine sulfate and re-positioned the patient prior to visiting another patient a couple of doors down. When the nurse returned to the room, the patient was experiencing a hemorrhagic death with an approximate blood loss of 1000ml. The staff attempted to resuscitate the patient, without success. Furthermore, the staff believe the patient overstretched the tubing set, at which time it snapped, causing a disconnection from the central line, a few inches before the secure lock.
 
Manufacturer Narrative
Testing and investigation confirmed the actual sample involved in the reported event was not returned for evaluation. The customer did not provide a sister sample, photographs or videos. Additionally, the customer was unable to identify the lot number of the device; therefore, a batch record review could not be performed. Testing completed a search of the reported list number, by the customer in the last two years, no similar defects were reported. The complaint could not be confirmed and a probable cause was not determined due to the absence of the product, sister sample, photographs and videos for evaluation.
 
Manufacturer Narrative
The customer provided pictures of a separation of a male luer from an unused tubing set. However, the set in the picture, was not the set involved in the actual incident, which was discarded by the user facility. The customer opened several packages and could easily pull the tubing away from the male luer, which indicated intentional manipulation of the unused set in an attempt to pull the tubing out. Testing confirmed the amount of tension the customer applied to the tubing could not be quantified. Sister samples were not provided, and attempts were made to identify the lot number, which was unsuccessful. A manufacturing batch record review could not be performed due to the unknown lot number; thus, a comprehensive failure investigation and a root cause could not be determined.
 
Manufacturer Narrative
An additional picture was provided by the customer documenting what appears to be a separated male luer on a list (b)(4) set. The separated male luer is still attached to what appears to be an introducing catheter of unknown manufacturer. A probable cause of what appears to be a separated male luer cannot be determined without the return of the product samples.
 
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Brand NameLIFESHIELD PRIMARY PLUMSET CLAVEPORT, CLAVE Y-SITE 103 INCH, NON-DEHP
Type of DeviceADMINISTRATION SET
Manufacturer (Section D)
ICU MEDICAL COSTA RICA LTD
zona franca global
la aurora heredia N/A
CS N/A
Manufacturer Contact
michael visocnik
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key8151641
MDR Text Key129937475
Report Number9615050-2018-00108
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 Risk Manager
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number146870438
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
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: 12/11/2018 Patient Sequence Number: 1
Treatment
MORPHINE SULFATE; NORMAL SALINE
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