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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. NEUTRON CONNECTOR

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ICU MEDICAL, INC. NEUTRON CONNECTOR Back to Search Results
Model Number 081-NC100
Device Problem Reset Problem (3019)
Patient Problem Respiratory Distress (2045)
Event Date 10/24/2017
Event Type  Death  
Manufacturer Narrative
Device return: five (5) used 081-nc100 neutron connectors were returned for analysis and investigation. Although requested the involved mating and access devices were not returned. Engineering testing and analysis of the five returned used 011- nc100 neutron connectors recorded two of the neutron connectors met initial pressure leak criteria, per the performance specifications. The remaining three 081-nc100 neutron connectors exhibited extensive component damages including slit propagation that resulted in silicone seal stick downs with two of the three, and internal leakage with the third. Findings: engineering testing and analysis of the devices recorded various component damages observed around the silicone seal. The characteristics of the component damage indicates unusual conditions of use, perhaps with either incompatible devices or due to extensive reuse. The dfu indicates that reuse can potentially result in degradation of performance.
 
Event Description
International ((b)(6)) complaint received reporting component (recessed silicone) issue with use of 081-nc100 neutron connectors. The initial information received describes the (b)(6) event as follows "two neutron was attached with picc-double lumen by nihon covidien. Regarding one of them, the silicone plug didn't return to the normal position. ". The neutron connectors were pretested/primed prior to placement at unknown time ( either (b)(6)). Followup information (as translated) reports pt. Was receiving high calorie infusions via picc / neutron connector set-up and unspecified syringe access devices. On (b)(6) " infusion fluid was delivered through the green line from 18:00. Through 6:00 and 10:00-11:00 the following day. " at an unspecified time following infusion treatment attending clinicians noted ". A small amount of air flowed into the heparin-locked green line. When the catheter of this line was refilled with heparin solution, a small amount of air was found to flow into the catheter several minutes later. Because the catheter itself was found intact, problem of the connector (neutron) was suspected and it was replaced with a new one. No air flow was noted (normal) when the new one was refilled with heparin. " on (b)(6) at 6:00 and 8:00 (pt. ) observed to be in "slight respiratory distress. But oxygenation improved while clinical course was being observed. Severe respiratory distress occurred suddenly with a drop in blood pressure at 11:18. Echocardiography showed micro bubbles in the right and left atria and left ventricle. Mill wheel noise was heard in chest auscultation, suggesting the presence of air embolization. Disturbance of consciousness and left hemiplegia occurred thereafter. The diagnosis of cerebral infarction was made in the absence of hemorrhage or tumor in head ct. Convulsive seizures and disturbance of consciousness occurred twice in the afternoon. " on (b)(6) " convulsive seizures and disturbance of consciousness occurred repeatedly in the evening, and the patient passed away at 21:57 following aggravation of disturbance of consciousness. " the hospitals initial assessment of the neutron connectors that were removed on (b)(6) found the ". Syringe/infusion set junction (silicone seal) was found to be partly invisible. The silicone was disrupted, resulting in negative pressure in the route and air entry. ". The facility incident report /medical reporter also acknowledges and states "the fatal outcome may have been attributable partly to the patient's specific condition, such as the suspected presence of right and left atrial shunt. ".
 
Manufacturer Narrative
Initial analysis: (b)(4) used 081-nc100 neutron connectors were returned for analysis and investigation. Although requested, the involved mating and access devices were not returned. Initial engineering testing and analysis of the five returned used 011- nc100 neutron connectors recorded two of the neutron connectors met initial pressure leak criteria, per the performance specifications. The remaining three 081-nc100 neutron connectors exhibited extensive component damages including slit propagation that resulted in silicone seal stick downs with two of the three, and internal leakage with the third. Preliminary findings: engineering investigations are in progress. Preliminary indications are that the component damages observed around the silicone seal indicates unusual conditions of use, perhaps with either incompatible devices or due to extensive reuse. The dfu indicates that reuse can potentially result in degradation of performance. The investigation is ongoing and the conclusions listed here are subject to change based on any new information that might become available.
 
Event Description
International ((b)(6)) complaint received reporting component (recessed silicone) issue with use of 081-nc100 neutron connectors. The initial information received describes the (b)(6) event as follows "two neutron was attached with picc-double lumen by nihon covidien. Regarding one of them, the silicone plug didn't return to the normal position. ". The neutron connectors were pretested/primed prior to placement at unknown time ( either (b)(6)). Followup information (as translated) reports pt. Was receiving high calorie infusions via picc / neutron connector set-up and unspecified syringe access devices. On (b)(6)" infusion fluid was delivered through the green line from 18:00. Through 6:00 and 10:00-11:00 the following day. " at an unspecified time following infusion treatment attending clinicians noted ". A small amount of air flowed into the heparin-locked green line. When the catheter of this line was refilled with heparin solution, a small amount of air was found to flow into the catheter several minutes later. Because the catheter itself was found intact, problem of the connector (neutron) was suspected and it was replaced with a new one. No air flow was noted (normal) when the new one was refilled with heparin. " on (b)(6) at 6:00 and 8:00 (pt. ) observed to be in "slight respiratory distress. But oxygenation improved while clinical course was being observed. Severe respiratory distress occurred suddenly with a drop in blood pressure at 11:18. Echocardiography showed micro bubbles in the right and left atria and left ventricle. Mill wheel noise was heard in chest auscultation, suggesting the presence of air embolization. Disturbance of consciousness and left hemiplegia occurred thereafter. The diagnosis of cerebral infarction was made in the absence of hemorrhage or tumor in head ct. Convulsive seizures and disturbance of consciousness occurred twice in the afternoon. " on (b)(6)" convulsive seizures and disturbance of consciousness occurred repeatedly in the evening, and the patient passed away at 21:57 following aggravation of disturbance of consciousness. " the hospitals initial assessment of the neutron connectors that were removed on (b)(6) found the ". Syringe/infusion set junction (silicone seal) was found to be partly invisible. The silicone was disrupted, resulting in negative pressure in the route and air entry. ". The facility incident report /medical reporter also acknowledges and states "the fatal outcome may have been attributable partly to the patient's specific condition, such as the suspected presence of right and left atrial shunt. ". The involved 061-nc100 neutron connectors were released and returned to the manufacturer. Device investigation is in progress.
 
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Brand NameNEUTRON CONNECTOR
Type of DeviceNEUTRON CONNECTOR
Manufacturer (Section D)
ICU MEDICAL, INC.
4455 atherton dr.
salt lake city 84123
Manufacturer (Section G)
ICU MEDICAL, INC.
4455 atherton dr.
salt lake city 84123
Manufacturer Contact
terry scesny
4455 atherton drive
salt lake city, UT 84123
8012641400
MDR Report Key7069100
MDR Text Key106173736
Report Number2025816-2017-00249
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K100434
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number081-NC100
Device Catalogue Number081-NC100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/30/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/29/2017 Patient Sequence Number: 1
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