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

Catalog Number	CH2000S
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation- the investigation is pending.
Event or Problem Description
The event occurred on 5/12/2024 and 5/19/2024 involving a spinning spiros®, closed male luer.It was reported that they had two incidents of a spiros cap disconnecting with blinatumomab infusing.It disconnected on the patient end of the spiros.They do not have the lot number for any of the products and staff only saved one spiros.The patient's line became disconnected 3 times during the week of 5/12-5-18 causing 3 bags of immunotherapy to spill and be wasted.Patients received a full dose of therapy with no signs of infection.There was patient involvement and unknown harm reported.
Additional Manufacturer Narrative
Received one used ch2000s-c spinning spiros and one used list #unknown extension set for inspection.As received, the spiros was separated from the extension set.The spin feature of the spiros was activated and spinning freely.No spline damage or shear tab anomalies were observed.Residual fluid was observed in the spin feature mechanism.The spiros was functionally and dimensionally tested and met product specifications.The reported complaint of separation can be confirmed.The probable cause is unknown.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: SPINNING SPIROS®, CLOSED MALE LUER
• Common Device Name: CLOSED 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19585104
• Report Number: 9617594-2024-00797
• Device Sequence Number: 14311130
• Product Code: ONB
• UDI-Device Identifier: 00840619033903
• UDI-Public: (01)00840619033903
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CH2000S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BLINATUMOMAB, MFR UNK.
• Patient Sex: Unknown