• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS, CLOSED MALE LUER CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS, CLOSED MALE LUER CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Model Number CH2000S
Device Problems Fluid Leak (1250); Separation Problem (4043)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/30/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant product - unspec needleless connector, mfr unk; unspec primary tubing, mfr unk; chemoclave bag spike, ln ch-10, lot #unk, mfr icu medical, inc. ; 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap, ln ch3034, lot #unk, mfr icu medical, inc. ; unspec chemotherapy, mfr unk. No product samples, videos, or photographs were returned for investigation. The device history review (dhr) for lot number 3786892 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint. A probable cause cannot be identified based on the information that has been provided.
 
Event Description
The event involved a spinning spiros® closed male luer that disconnected or separated resulting in a chemotherapy spill. It was reported that the chemo bag was spiked with a chemoclave bag spike, which was connected to 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap, then connected to primary tubing with the spiros at the end attached to the needleless connector. It was reported that 15 minutes after hanging chemotherapy, the patient alerted the nurse to a disconnection in iv tubing. The inner tube of the spiros was found detached from the outer encasement. The inner tube was found connected to the iv tubing and the outer encasement of the spiros remained connected to the needleless connector. The chemo spill was cleaned as per facility protocol. The tubing was replaced, the drug replaced and therapy resumed. There was patient involvement, no patient harm, no medical intervention required.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSPINNING SPIROS, CLOSED MALE LUER
Type of DeviceCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
ensenada, b.cfa. 22790
MX 22790
Manufacturer Contact
michael visocnik
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key10338989
MDR Text Key203127727
Report Number9617594-2020-00275
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K173477
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCH2000S
Device Catalogue NumberCH2000S
Device Lot Number3786892
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 Received07/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-