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

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.

• Brand Name: IV CONNECT INVISION PLUS CAP
• Type of Device: SET, ADMINISTRATION
• Manufacturer (Section D): RYMED TECHNOLOGIES
• MDR Report Key: 6705810
• MDR Text Key: 79966013
• Report Number: MW5070918
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• 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 Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1051
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR