MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 140013190

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.It has not been received.

Event Description

The event involved primary plumset that the customer reported at the time of using the device, it was noted to have foreign coffee brown particles in the drip chamber.The set was changed for another one from a different lot to continue the infusion process of the medicine.Although there was a patient mentioned in the report, the event did not occur during patient use, and no one was harmed as a result of the event.

Manufacturer Narrative

Received opened/unused list #140013190, primary plum set, 15 micron filter in sight chamber, clave secondary port, clave y-site, secure lock, 272 cm; lot #5409195 was received for evaluation.Received one photo showing the brown spot on the drip chamber.The second showing the packaging.The complaint of brown spots on the drip chamber of the 140013190, primary plum set, 15 micron filter in sight chamber, clave secondary port, clave y-site, secure lock, 272 cm; lot #5409195 could be confirmed.There were multiple brown spots visible on the drip chamber.The drip chamber was cut open and the particles were confirmed to be embedded in the drip chamber wall, not in the fluid path.The larger particles were found to be larger than or equal to 1.00 mm^2 when compared to the size estimation chart.The combined area of these particles far exceeds the allowable surface area of embedded or attached foreign material per product specifications.While the device fails visual inspection, the embedded material is not in the fluid path, and does not affect the functionality of the device.The most probable cause is due to a vendor related issue.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information in d9 - date returned to mfg - december 16, 2021.

• Brand Name: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE
• 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: 12957082
• MDR Text Key: 283154353
• Report Number: 9615050-2021-00171
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887709100883
• UDI-Public: (01)10887709100883(17)240601(10)5409195
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

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 Expiration Date: 06/01/2024
• Device Catalogue Number: 140013190
• Device Lot Number: 5409195
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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