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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RYMED TECHNOLOGIES IV CONNECT INVISION PLUS CAP SET, ADMINISTRATION

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RYMED TECHNOLOGIES IV CONNECT INVISION PLUS CAP SET, ADMINISTRATION Back to Search Results
Lot Number 1051
Device Problems Detachment Of Device Component (1104); Crack (1135); Material Fragmentation (1261)
Patient Problems Dyspnea (1816); Hyperventilation (1910); Swelling (2091); Blood Loss (2597); Test Result (2695)
Event Date 06/23/2017
Event Type  Injury  
Event Description
Pt's wife reports that on (b)(6) 2017 the pt was dry heaving. When the wife went to his assistance. She found that the tubing had disconnected from the iv connect invision plus cap and there was blood all over. The iv connect invision plus cap was still connected to pt's central line. She states that the blood was coming from the broken iv connect invision plus cap. She states that the cap cracked at the threading. She placed a new iv connect invision plus cap, used a new cassette of veletri and reconnected him to his pump. He was in no distress due to being off of the veletri for an unk amount of time. She called 911 and the pt was taken to the er for eval. He was not admitted since he remained stable. Pt then saw md for a f/u appointment on (b)(6) 2017. Md found his legs to be swollen. His creatinine was elevated at 4. 3 so he was readmitted to the hospital. Upon the rn at the hospital switching pt from his home veletri pump to the hospital pump, they found his iv connect in vision plus cap was cracked at the threading again. She believes the lot numbers of the broken caps are either 1051 and/or 1047. She no longer has the caps for eval. Pt remains in the hospital on an iv bumex drip. They are hoping to switch him from a veletri to tyvaso. Dates of use: (b)(6) 2017 to present. Reason for use: pah.
 
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Brand NameIV CONNECT INVISION PLUS CAP
Type of DeviceSET, ADMINISTRATION
Manufacturer (Section D)
RYMED TECHNOLOGIES
MDR Report Key6705810
MDR Text Key79966013
Report NumberMW5070918
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/05/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1051
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/07/2017 Patient Sequence Number: 1
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