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	01/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation.Investigation is pending.
Event or Problem Description
The customer reported a issue with 14" bifuse add-on set w/bag spike, spiros® w/red cap, vented cap that during the chemotherapy treatment, the nurse noticed after the priming some drops like beads on the tubing at the y connector.The device did not leak when primed with physiological serum.The infusion line was changed to make the chemotherapy pass through checking that the system is indeed occlusive.There was chemotherapy exposure for the healthcare provider.There was patient involvement and no report of an adverse event or harm.
Additional Manufacturer Narrative
Received one used list #ch3033, 14" bifuse add-on set w/bag spike, spiros® w/red cap, vented cap; lot #5643101.Received one used list #unknown, 0.9% nacl 100ml bag; lot #21l10g61.Received one used manufacturer unknown, piercing pin with drip chamber tubing set; lot #unknown.As received, a used ch3033 bifuse add-on set was returned with an unidentified pump set drip chamber spike inserted into the adapter tubing.Subsequent testing revealed a puncture and subsequent leakage in the ch3033 bifuse add-on set adapter tubing adjacent to the drip chamber spike tip of the unidentified pump set drip chamber spike.The probable cause is typical of an inadvertent puncture of the ch3033 bifuse add-on set adapter tubing by the unidentified pump set drip chamber spike during insertion into the adapter tubing during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information in section b5 and d10.Corrected information in section a1, a2, and a3.
Event or Problem Description
Additional information received.The customer reported that the patient had no change in condition after the event.The drug being administered was doxorubicine.There was no need for medical intervention, the infusion line was replaced.There was no delay in therapy and no blood loss.The leak was not in contact with the patient.As for the healthcare provider, there was no impact reported.The infusion line was changed following the dedicated protection measures.No medical intervention needed for the healthcare provider.The leak was cleaned-up as per facility¿s protocol.There were no reports of adverse events and no human harm.

• 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13497474
• Report Number: 9617594-2022-00018
• Device Sequence Number: 4025676
• Product Code: ONB
• UDI-Device Identifier: 00840619024109
• UDI-Public: (01)00840619024109(17)261001(10)5643101
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: 10/01/2026
• Device Model Number: CH3033
• Device Catalogue Number: CH3033
• Device Lot Number: 5643101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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: DOXORUBICINE, UNK MFR; PHYSIOLOGICAL SERUM, UNK MFR; UNKNOWN CHEMOTHERAPY, UNK MFR
• Patient Age: 16 YR
• Patient Sex: Female