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 140019291

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/13/2023

Event Type  malfunction  

Event Description

The event involved a primary plum set, 15 micron filter in sight chamber, clave secondary port, clave y-site, secure lock, 272 cm where it was reported there was leakage from the online filter giving set.The event occurred during the flushing of the line after paclitaxel administration.The customer became aware of the event when the patient complained of a wet arm.The medication came in contact with the patients arm but not with the health worker due to the health care worker wearing personal protective equipment (ppe).There was no impact to the patient/health care provider.The chemo spill was cleaned up according to local health protocols.A spill kit was not required because spill was on blue sheet under patient's arm.The product was not reprocessed or re-sterilized prior to use.There was patient involvement but no delay in therapy and no patient harm.

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.If the device is returned an additional report will be submitted.

Manufacturer Narrative

Received three photos showing fluid outside of the fluid path and leakage from the micron filter.The reported complaint of leakage can be confirmed on the primary plum set.The probable cause is unknown.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) for lot 13547468 was reviewed and no non conformities were found that would have led to the reported complaint.

• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18111687
• MDR Text Key: 328509814
• Report Number: 9615050-2023-00623
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887709100128
• UDI-Public: (01)10887709100128(17)260401(10)13547468
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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: 140019291
• Device Lot Number: 13547468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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: PACLITAXEL; UNSPECIFIED FLUSH, UNK MFR