MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. INTERN III SYSTEM SCHENKEL RECHTS; STOPCOCK, I.V. SET

Catalog Number SN1070

Device Problem Fluid/Blood Leak (1250)

Patient Problems Sepsis (2067); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

The event involved an intern iii system schenkel rechts.The customer reported that on an unspecified date between (b)(6) 2023 and the beginning of (b)(6) 2024, the red infusion systems were leaking again and again during infusion.It was independent of the batch and also of the run rate.The customer works with immunocompromised patients on the kiis3.The leaking infusion systems mean more frequent system changes, which always poses a risk of infection.The customer added that the event occurred again and again since the last report last year.When asked what was the status of the product when the problem occurred, it was answered as "externally undamaged, new packaging." there was no holes, cut, tears and defects noted.The medication involved is 0.45% nacl0.9%+2.5% glucose from serag wiessner.When asked if the chemo did come into contact with the patient or healthcare provider, it was answered as "it is not possible to say exactly, as the defect is located above the filter, but if there is a backflow upwards via the filter, this may be possible.The defect is located above the filter.We administer the chemotherapies below the filter at the y-pieces." there was a potential infection at the catheter.If asked if there was unprotected chemo exposure, it was answered "not visible, may be possible." the chemo spill was not cleaned as per facility protocol and no spill kit was used.The incident occurred while patient use and sometimes the patient reported that the infusion system was wet and dripping.The product problem could possibly contribute to catheter infections.There was also a medical intervention required: therapy for catheter sepsis.There are no relevant tests or lab data available, because the observation that systems repeatedly leak raises the suspicion as to whether external contamination also occurs and promotes a catheter infection.As a relevant medical history the customer mentioned the fact that all patients are immunosuppressed due to chemotherapy for tumor diseases and the patient received medical treatment.There was patient involvement but no patient harm.

Manufacturer Narrative

E1 - initial reporter phone is (b)(6).The device is available to be returned for evaluation; however, it has not yet been received.

• Brand Name: INTERN III SYSTEM SCHENKEL RECHTS
• Type of Device: STOPCOCK, I.V. SET
• 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: 18798529
• MDR Text Key: 337620494
• Report Number: 9617594-2024-00206
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2024

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: SN1070
• Device Lot Number: 13759007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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: 0.45% NACL0.9%+2.5% GLUCOSE, SERAG WIESSNER MFR