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

Model Number CH2000S-C

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not being returned for evaluation.Without the returned device a probable cause is unable to be determined.

Event Description

The event involved a spinning spiros closed male luer, red cap.It was reported that the item disconnected and was leaking an unspecified chemotherapy.It was also reported that there were no obvious defects noted on the tubing set.It was reported that the set was connected to the patient and infusing.It was stated there may have been some blood backed up into the central line, but there was no report of blood loss.It was reported the nurse was called in to the room by the patient¿s family.At this time, the nurse noticed the patient¿s gown and bed to be wet with hazardous medication.It was reported that the nurse may have had unprotected exposure to chemotherapy before realizing what was leaking onto the patient¿s bed and gown.Therefore, it was reported that the nurse was unable to get on proper personal protective equipment (ppe).It was also reported there was a delay in therapy since a new chemo bag needed to be ordered from pharmacy.There was patient involvement and no report of harm.This captures the second of two events.

• 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 12938512
• MDR Text Key: 282127133
• Report Number: 9617594-2021-00302
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)260301(10)5208921
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH2000S-C
• Device Catalogue Number: CH2000S-C
• Device Lot Number: 5208921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• 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: UNSPECIFIED CENTRAL LINE, MFR UNK; UNSPECIFIED CHEMOTHERAPY, MFR UNK; UNSPECIFIED TUBING SET, MFR UNK
• Patient Sex: Male