MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS W/RED CAP, VENTED CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CH3033
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not been received.
Event or Problem Description
The event involved a 14" bifuse add-on set w/bag spike, spiros® w/red cap, vented cap that the customer observed a leak of mitoxantrone at the y-tubing 10 minutes after the start of the chemotherapy.There was no leak observed on the y-tubing during the preparation of chemotherapy.The tubing was changed and the chemotherapy remaining in the bag was administered.The customer reported there was incomplete chemotherapy administration with a loss of 7 ml of the mitoxantrone.The event occurred on a pediatric unit and the patient was hospitalized for chemotherapy treatment for acute lymphoblastic leukemia discovered in (b)(6) 2020.There were no physical defects observed on the device.There was patient involvement and unprotected exposure to chemotherapy, however, no report of adverse event, no negative consequence for the patient, no medical intervention needed, and no delay in therapy.
Additional Manufacturer Narrative
Received one use.List #ch3033, 14" bifuse add-on set w/bag spike, spiros® w/red cap, vented cap; lot #5186709 on june 15, 2021 for evaluation.The complaint of leakage could not be confirmed on the returned one used list #ch3033, 14" bifuse add-on set w/bag spike, spiros® w/red cap, vented cap.The device was leak tested per product specification.There were no leaks anywhere along the device.The returned one used list #ch3033, 14" bifuse add-on set w/bag spike, spiros® w/red cap, vented cap met product specification.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS W/RED CAP, VENTED CAP
• 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
• MDR Report Key: 11851759
• Report Number: 9617594-2021-00162
• Device Sequence Number: 11693515
• Product Code: ONB
• UDI-Device Identifier: 00840619024109
• UDI-Public: (01)00840619024109(17)260201(10)5186709
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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 Expiration Date: 02/01/2026
• Device Model Number: CH3033
• Device Catalogue Number: CH3033
• Device Lot Number: 5186709
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MITOXANTRONE, MFR UNK.; MITOXANTRONE, MFR UNK
• Patient Age: 7 YR