MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, BALL CHECK VALVE IN SIGHT CHAMBER, 15 MICRON FILTER, CLAVE SEC; ADMINISTRATION SETS AND ACCESSORIES

Catalog Number 142409291

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for further evaluation.

Event Description

It was reported that, on an unknown date, the primary plum set, experienced a chamber filter leak of unknown chemotherapy medication.The reporter stated, the duration of the procedure was approximately 5 hours.There was no report of patient harm as a result of the incident.No additional information is available at this time.This captures 1 of 3 incidents.

Manufacturer Narrative

The device was not returned.The lot history was evaluated and no nonconformities were found which would have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, BALL CHECK VALVE IN SIGHT CHAMBER, 15 MICRON FILTER, CLAVE SEC
• Type of Device: ADMINISTRATION SETS AND ACCESSORIES
• 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: 12682761
• MDR Text Key: 284199268
• Report Number: 9617594-2021-00286
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887709100340
• UDI-Public: (01)10887709100340(17)240601(10)5409076
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 142409291
• Device Lot Number: 5409076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2021
• 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
• Treatment: UNSPECIFIED CHEMOTHERAPY, MFR UNK