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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 140019291
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anaphylactic Shock (1703); Death (1802)
Event Date 09/01/2020
Event Type  Death  
Manufacturer Narrative
The device is not available for evaluation. Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined. If additional information becomes available, a supplemental report will be submitted. Concomitant products: vygon polysite implantable chamber ref vpe4008isp lot: 17035004; hubert vygon needle ref 722009 lot 20035012; bd peripheral catheter ref 393222 lot 9317628p01; didactic single 3-way infusor ref per3f25bpaf batch not recorded; 28 cm (11 in)appx 2. 5ml, set ambrato per infusione, 2 clave ref 011-h1367 lot 4867093; 15 units of ext set tubing pur yellow with spike, y-clave®, clamp, luer check valve ref 011-h2771 lot 4184527; 200mg/557 ml of accord oxaliplatinum lot p2000418, exp 12/31/2021 in g5% 500ml, lot 14ni7321, exp 08/2021 freeflex fresenius; avastin bag, batch n7436h05, exp 31/01/2022 (435 mg/121ml) in 0. 9% nacl solution 100ml, lot 13pbs105, exp. 01/2022 freeflex.
 
Event Description
The event involves a primary plum set, 15 micron filter in sight chamber, clave secondary port, clave y-site, secure lock, 272 cm. The customer reported a (b)(6)-year old male patient who suffered anaphylactic shock. Additionally, the patient suffered cardiac arrest which resulted in death on (b)(6) 2020 probably due to the anaphylactic shock. Infusion placement on the port-a-cath: avastin bag 435 mg/121 ml in 0. 9% nacl solution - 100 ml, freeflex over 1h starting at 12:30 p. M. (the entire bag passed over 1 hour) - oxaliplatin bag 200 mg/557 ml in g5% 500 ml solution freeflex programmed for 3 hours (approximately 15 cc passed). At the same time, the patient was infused on the peripheral route with a physiological serum y-shaped bag. The patient was administered rbc (red blood cell concentrate) on a peripheral kt bd + didactic infuser then cgr, not infusing through the plum set. The patient alerted the staff they had hot flashes with a red face. Immediate stop of oxaliplatin infusion (which was almost finished). Immediate injection of 1 vial of polaramine. Patient has difficulty breathing. The o2 bottle was taken out and the doctor was called. When the nurse returned to the room, the patient was no longer aware of the doctor being already there. Cardiac massage followed, and a smur (emergency mobile resuscitation unit) appeal. 100mg of hydrocortisone (hshc) was injected. Then after a long resuscitation the patient was transferred to the intensive care unit and expired a few days later. Additional medications were administered as part of the patient¿s intensive care; however, the details of the medications were not provided. As the incidence of hypersensitivity reactions seems to have increased in the last few months the customer has looked for anything that may have changed in their care and the most recently introduced device is the plum pump tubing from icu, which has been introduced in (b)(6) 2020. Nothing explains the increase in hypersensitive reactions these past few months, so they are expanding their field of research to the medical devices. Other devices used during the incident include: vygon polysite implantable chamber, hubert vygon needle, tubing for icu pump, 2v icu shaft ref 011-h1367, extension for icu bag ref 011-h2771, bd peripheral catheter, and didactic single 3-way infusor. The 2iv icu shaft ref 011-h1367 was connected to the vygon cip at the level of the central channel, the vygon huber needle, then tubing for icu plum pump, then 2v ivu shaft, then icu extension, then oxaliplatin bag. The icu bag extension ref 011-h2771 was connected to the oxaliplatin bag on one side and the 2-way extension on the other side.
 
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Brand NamePRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE
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 Key10579404
MDR Text Key208305602
Report Number9615050-2020-00219
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K141789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number140019291
Device Lot Number4495821
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2019
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: 09/24/2020 Patient Sequence Number: 1
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