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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

The event involved a spinning spiros® closed male luer, red cap where it was reported an incident of chemotherapy spillage due to a disconnection between male luer and kabi infusion set during patient use in the recent 3 months out of 500 usages of spiro.There was physical damage noted on the device at the connection area between the end of tail of spiros and the end of kabi infusion set.There was little amount of spillage but unable to measure.Leakage was confirmed.The event was noted during chemotherapy on patient, leakage happened after +10hrs of continuous infusion.There was unprotected chemotherapy exposure to the patient, health care worker or other personnel.There was chemotherapy exposure to the to the patient, health care worker or other personnel.The chemo spill was cleaned up per facility protocol and a spill kit was used.There was patient involvement and but no patient harm.This is the first of two events.

Manufacturer Narrative

One photo was shared by customer, where is observed a spiros connected into unknown set, there are 2 red arrow pointed the apparently the location of the leaks.However no leaks are observed.No additional damage or anomalies were observed.Complaint of disconnection cannot be confirmed based on photo shared by customer.However, without the return of the affected item for investigation, a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history report (dhr) lot#13619409 was reviewed and no non conformities were found that would have led the reported complaint.

• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18132402
• MDR Text Key: 328065134
• Report Number: 9617594-2023-00981
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)280401(10)13619409
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: Other
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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: 13619409
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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 CHEMOTHERAPY, MFR UNK; UNSPECIFIED INFUSION SET, FRESENIUS KABI