MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS® W/RED CAP, VENTED CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number CH3034

Device Problem Fluid/Blood Leak (1250)

Patient Problems High Blood Pressure/ Hypertension (1908); Rash (2033); Tachycardia (2095); Chest Tightness/Pressure (2463)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

Plots: lot# 4080722, mfr date 2019-05-01, expiration date 2024-05-01; lot# 4104223, mfr date 2019-05-01, expiration date 2024-05-01.The device was discarded.There are no sister samples available for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.

Event Description

The event involves a bag spike adapter w/spiros s/red cap vented cap, ch3034.The customer reported line a is the only line used and primed with chemo.A ch-14, chemoclave vented bag spike, was inserted into the mab (pembriluzimab) and the ch3034 attached to the plum set then attached to the ch-14 device.The nurse picked both items up out from the tray, the spiros disconnected and drops of mab went onto her forearm and the floor.The area was washed immediately with soapy water per hospital protocol.The nurse had tachycardia and raised blood pressure.She had a rash on her front and back trunk that went up her neck with chest tightening.She was sent to a&e (accident and emergency department) for treatment, was prescribed cetirizine and paracetamol, and referred to occupational health.By 8pm, the nurse was feeling much better, observations back to normal.The nurse was wearing personal protective equipment during the event.The chemo spill was cleaned up per protocol with a spill kit.There was a delay of therapy for 30 minutes with no effect on the patient.No additional information has been provided.

Manufacturer Narrative

H10: no product samples were returned for investigation, however, a very small photograph was returned identifying the separation at the bond interface between the female luer of the spinning spiros and the male luer of the x1-4736 sub-assembly of the ch3034.Based on prior complaints this complaint is confirmed.The probable cause is an insufficient bond during manual assembly in ensenada.The device history reviews for lots 4080722 and 4104223 were reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.Additional information in h3 and h6.

• Brand Name: 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS® W/RED CAP, VENTED CAP
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 9516637
• MDR Text Key: 219778867
• Report Number: 9617594-2019-00431
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: K173477
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH3034
• Device Catalogue Number: CH3034
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CHEMOCLAVE VENTED BAG SPIKE, CH-14.; PEMBRILUZIMAB, UNK MFR.; PLUM SET.