MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2066828

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation; however, a sister sample will be returned for evaluation.Concomitant products: etoposide, mfr unknown; vincristine, mfr unknown; doxorubicin, mf unknown; spinning spiros, icu medical, list # k7040-001, plots; primary plum set, icu medical, list# unknown, lot# unknown.

Event Description

The event occurred overnight from (b)(6) 2019.The customer reported a 0.2 micron filter extension set leaked during a 24 hour chemotherapy infusion of a combination of doxorubicin, vincristine and etoposide.The patient noted a wet spot on her filter or hand, so first the nurse had the patient thoroughly washed per chemotherapy spill policy.The nurse then put an absorbent pad on the filter to see if it was leaking.Although the nurse could not say for sure if it appeared to be slowly leaking, she removed the filter and applied a new one to minimize the risk of a larger chemotherapy spill and exposure.The customer reported the filter sets are placed at the distal end of a primary iv plum set with the spinning spiros at the end of the filter before the picc line.Some of the lines may have had a spinning spiros at the end of the primary tubing as well as at the end of the filter.The filter may have been used for up to 96 hours, as saskatchewan health authority policy indicates that iv tubing is safe to be used for that amount of time and the notice on the tubing bag also states to change at least every 96 hours.However, some rns would change the filter daily so the customer cannot say with certainty how long each filter was used before it leaked.There was patient involvement, but no harm reported.

Manufacturer Narrative

H10: no product sample was returned for investigation.The complaint of leakage cannot be confirmed.There was one black and white photo received.The quality of the photo is poor.It is unknown by the picture if the set is leaking or not.Without the return of the product a definitive confirmation and probable cause cannot be determined.The device history review could not be reviewed due to the unknown lot number.Additional information in b5, d10, and d11.D11 concomitant products: picc, mfr unknown; 0.9 normal saline, mfr unknown.

Event Description

Additional information received january 8, 2020 from the customer.The filter was not used daily on the oncology unit however, it was used in the treatment cocktail for a certain type of cancer.The cocktail of etoposide, vincristine and doxorubicin was mixed in 1 liter bag that runs over 24 hours.Prior to use of the device, it was flushed with 0.9 normal saline (ns) and nurses attach it via spiros to primary plum set and connects a spiros on the distal end as well and then to the patient¿s peripherally inserted central catheter (picc).The typical set up on the plum set is a primary line that has 0.9 normal saline (ns) and combination medication (etoposide/vincristine/doxorubicin mixed in 1 liter) was given on b line.The leaking has been difficult to determine on the filter as it does not occur with every infusion but has always with the combination of drugs.

• Brand Name: EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9531787
• MDR Text Key: 178617850
• Report Number: 9615050-2019-00481
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K151969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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 Model Number: 2066828
• Device Catalogue Number: 206680490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1