MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LIFESHIELD MICROBORE EXTENSION; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 0269428

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/01/2022

Event Type  malfunction  

Event Description

It was reported that the oncology unit has experienced leaking from their 0.2-micron filter tubing.It was indicated that it was specifically leaking from the filter.Their current practice is changing the tubing/filter after day 2 of administration.There were no issues noted during the initial priming/set-up of the set.It is unknown if the chemotherapy being used came in contact with the patient but unfortunately, some chemo was wasted because of the leaks.She confirmed that the chemo spill was cleaned up per facility protocol.There was no harm to the patient reported.No additional information is available.This is report 3 of 3.

Manufacturer Narrative

The actual sample was discarded, however, the customer returned one new unused lifeshield microbore extension from the same lot.The set was tested per product specification and no leakages were observed.The reported complaint of leakage was unable to be replicated or confirmed.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: LIFESHIELD MICROBORE EXTENSION
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15191264
• MDR Text Key: 302583088
• Report Number: 9615050-2022-00168
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005018
• UDI-Public: (01)10887787005018(17)231101(10)5082408
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 0269428
• Device Catalogue Number: 2694-28
• Device Lot Number: 5082408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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 CHEMO MEDICATION, UNK MFR