MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number CH2000S-PC

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Section e additional contact details: (b)(4).

Event Description

The complaint/event involved a spinning spiros® closed male luer, purple cap.A five year old child patient was getting a high-dose of chemotherapy (busulfan-melphalan) for high-risk neuroblastoma.Two hours after connecting the busulfan syringe (during infusion), the professionals were alerted by the patient's family due an early end of infusion alarm.Observation of chemotherapy on the ground and the disconnection of the spiros connector from the syringe.The valve was connected during preparation in the centralized unit and the connection checked during installation of the infusion.Clinical consequences: significant venous return and occlusion of the needle of the implantable catheter port.Removal of the a pulmonary artery catheter (pac) needle and installation of a new needle.A loss of opportunity was reported due to non-complete administration of chemotherapy.Application of the contact protocol with chemotherapy for professionals and the environment.The customer stated there were no noted undesirable clinical consequences and nobody has been hurt.There was no delay in therapy.There was no blood loss considered clinically significant.The leak did not come into contact with the patient and there was no unprotected exposure to chemotherapy for the patient.A specific kit was used to clean the leak.The patient did not receive the full intended dose.About the patient's condition before, during and after the incident, it was reported that there was nothing to signal.No other information was provided.

Manufacturer Narrative

One used spinning spiros closed male luer, purple cap, one used 50ml syringe, and one used 4-way stopcock w/ tubing were provided by the customer for evaluation.The spiros came disconnected from the 50ml syringe.As received, no damage was noted on the spiros or the 4 way stopcock.Damage on the threads of the 50 ml syringe male luer was also identified.The spin feature of the spiros was functionally tested and met product performance specifications.The luers of the returned syringe was also analyzed and met iso standards for luer fittings.The reported complaint of a disconnection and subsequent leakage can be confirmed based on the spiros being disconnected from the syringe upon arrival.The probable cause of this separation is due to the damage found on the syringe threads typical of a bending force.A device history record review was performed and no relevant nonconformances were found.D9: date returned to mfg: 14dec2023.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18287673
• MDR Text Key: 330668466
• Report Number: 9617594-2023-01100
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: CH2000S-PC
• Device Lot Number: 5891845
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BUSULFAN-MELPHALAN, MFR UNK; UNSPEC. PULMONARY ARTERY CATHETER (PAC), MFR UNK; UNSPECIFIED SYRINGE, MFR UNK
• Patient Age: 5 YR