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 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device has been received for investigation.Investigation is pending.

Event Description

The event occurred on an unspecified date and involved a red infusion system which was reported to be leaking.The customer states that the patients are immunocompromised and the frequent system changes poses a risk of infection.The defect is located above the filter.The customer stated the chemotherapy is administered below the filter at the y-pieces.The incident occurred during patient use and sometimes the patient reported that the infusion system was wet and dripping.There was a medical intervention required: therapy for potential catheter sepsis.There are no relevant tests or lab data available, because the observation that systems repeatedly leaks raises the suspicion as to whether external contamination also occurs and promotes a catheter infection.As a relevant medical history, the client mentioned the fact that all patients are immunosuppressed due to chemotherapy for tumor diseases and the patient received medical treatment.No chemo spill kit was used and no protocol used for spilled chemotherapy.There was patient involvement, however no report of patient harm.

Manufacturer Narrative

Received one new and three used sn1070 intern iii system schenkel rechts and one used sn1071 intern iii system schenkel links for inspection.No defects or anomalies noted.Each set was connected from each microclave and nanoclave and was leak tested.There was no leakage from any of the sets or connections.The reported complaint of leakage was unable to be replicated or confirmed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Additional information in b5 and h6.

Event Description

Additional information received on (b)(6) 2024 where the customer provided what interventions were taken regarding the therapy for catheter sepsis.The customer stated that "antibiotic treatment over several days, catheter revision in individual cases and there were patients with confirmed sepsis.

• 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: 18766229
• MDR Text Key: 336972534
• Report Number: 9617594-2024-00191
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNSPECIFIED CHEMOTHERAPY, UNK MFR.