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

Catalog Number CH2000S-C

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

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570); Blood Loss (2597)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned.The device is not yet received.

Event Description

The event involved a spinning spiros® closed male luer, red cap that disconnected from the distal end and leaked cytarabine or cisplatin, at variable times for 6 doses, some happening at the beginning and some toward the end of infusion.A bd alaris buretrol was spiked into an iv bag, then a spiros was connected to the distal end of the tubing set.The chemo was primed by the pharmacy in a chemo hood.The rotating collar came loose and the spiros became detached from the distal slip tip end of the buretrol tubing during chemotherapy infusion.The spiros stayed secure to the patient¿s access and when the buretrol line came loose, the patient bleed from the back end of the spiros opening.There was a report of sufficient blood loss, although there was no adverse event or patient harm reported.The chemotherapy drug came into contact with the patient, patient¿s family, and healthcare worker.The hospital staff cleaned per protocol immediately upon notification.There was patient involvement and delay in therapy as medications had to be stopped during spill and re-doses and re-prepared, which added an additional day of therapy for the patient.This report captures the fifth of six events.

Manufacturer Narrative

H10 - one new list# (b)(4), spinning spiros® closed male luer, red cap.Lot# 4461372.The single new ch2000s-c spinning spiros was pressure leak tested and the new assembly met pressure leak expectations outlined in the product performance specification.The complaint of leakage was unable to be confirmed.The spin feature of the single new ch2000s-c spinning spiros was evaluated and the spin feature met functionality expectations outlined in the product performance specification.The complaint of disconnect could not be confirmed.The device history review for lot 4461372 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.D10 - date returned to mfr - (b)(6)2020 additional information can be found in section e3.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER, RED 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
• MDR Report Key: 10370726
• MDR Text Key: 242645445
• Report Number: 9617594-2020-00294
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)241101(10)4461372
• Combination Product (y/n): N
• PMA/PMN Number: K082806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH2000S-C
• Device Lot Number: 4461372
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CISPLATIN.; CYTARABINE.; UNSPEC BURETROL TUBING SET, MFR BD ALARIS.