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

Model Number CH2000S

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

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

Event Date 02/07/2022

Event Type  malfunction  

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 1 of 2.

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).

• Brand Name: SPINNING SPIROS®, CLOSED MALE LUER
• Type of Device: 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: 13780844
• MDR Text Key: 292516582
• Report Number: 9617594-2022-00053
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K173477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• 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 Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CH2000S
• Device Catalogue Number: CH2000S
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• 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