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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

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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 Disconnection (1171); Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2022
Event Type  malfunction  
Manufacturer Narrative
The device was reported as being discarded. Without the return of the device, a comprehensive failure investigation cannot be performed and a cause cannot be determined. In the event that additional information becomes available; a supplemental report will be submitted. Additional information for lot no, expiration date, and device mfg date are as follow. The customer provided the possible lot numbers involved are 5471893 (expiry date 06/1/2026 , mfr date 06/01/2021), 5571647 (expiry date 08/01/2026, mfr date 09/01/2021), 5737340 (expiry date 12/01/2026, mfr date 12/1/2021).
 
Event Description
It was reported that the spinning spiros, used during the event, disconnected from the bd alaris pump infusion set during a dinutuximab infusion. The concentration of the medication was reported as 14mg of dinutuximab in 100ml ns, infusing through a central line. The clinician reported having properly secured the product by spinning it and checking for the ¿click¿ prior to starting the chemo infusion. The separation/disconnection occurred distal to the pump at the patient approximately 7-9 hours after the infusion was started. There was some bleed back/loss reported but it was not quantified. The therapy was resumed, the drug was not replaced. The setup was bd alaris pump infusion set low sorbing tubing with the spinning spiros connected to the end of the tubing and then connected to the patient. The patient was reported as very active but no harm was reported. No additional information is available at this time. This is report 2 of 2.
 
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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 Key13780830
MDR Text Key288626540
Report Number9617594-2022-00052
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173477
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCH2000S
Device Catalogue NumberCH2000S
Device Lot NumberPLOTS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/16/2022 Patient Sequence Number: 1
Treatment
BD ALARIS PUMP INFUSION SET; CENTRAL LINE, UKN MFR; DINUTUXIMAB, UKN MFR; NORMAL SALINE, UKN MFR
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