MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 0.2 M; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 140159291

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.

Event Description

The event involved a primary plum set, 15 micron filter in sight chamber, clave secondary port, 0.2 micron filter, clave y-site, polyethylene lined tubing, secure lock, 272 cm where leaking was reported.It was stated there was leaking from the corner of the filter, quite significantly at times.Someone became aware of the issue when leaking was noted from filter during delivery of fluid and medications.The medication used with the product was immunotherapy.The product was not reprocessed or re-sterilized prior to use.It was during use on a patient that the event occurred, and the product was in use for minutes.There were no holes, cuts, tears, or defects noted that can be seen by the naked eye.There was drug exposure to the patient, the spill was contained with personal protective equipment (ppe).There was no patient/ healthcare provider's impact.The chemo spill cleaned up per facility protocol, and spill kit used.The other product involved at the time of event was icu medical¿s plum set with list number 011-cl3020.There was patient involvement, with delay in therapy, but no one was harmed as a result of the reported event.This captures the second of two occurrences.

• Brand Name: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 0.2 M
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18397234
• MDR Text Key: 331366715
• Report Number: 9615050-2023-00814
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887709100197
• UDI-Public: (01)10887709100197(17)260701(10)13639954
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 140159291
• Device Lot Number: 13639954
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• 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: LN 011-CL3020, ADMINSET CL DC SPIROS BG HGR MFRICU.; UNSPECIFIED FLUIDS, UNK MFR.; UNSPECIFIED IMMUNOTHERAPY, UNK MFR.