MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 46 CM (18") APPX 5.7 ML, PUR TRANSFER SET W/CHEMOLOCK ADDITIVE PORT, 0.2 MICRON; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number 011-CL3955

Device Problem Inaccurate Delivery (2339)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

Event Description

The event involved a 46 cm (18") appx 5.7 ml, pur transfer set w/chemolock® additive port, 0.2 micron filter, check valve w/luer lock, filter cap in which the customer reported that they had been having issues with quite a lot of fluid remaining behind in the infusion bag.The customer reported that an air bubble develops in the tubing above the filter, not allowing the bag to empty completely, and the patient does not receive the full dose.The customer stated that they tried different things to get the remaining liquid out of the bag, via the pump and rolling up the bag.The event occurred in the oncology day-care hospital on an unspecified date.There was patient involvement but there was no harm reported as a consequence of this event.

Manufacturer Narrative

No product samples were returned for investigation, however, photographs were provided and evaluated.The photos show one 011-cl-3955 transfer set inserted into a bag of fluid and connected to another unknown transfer device.Air can be seen within the tubing of the 011-cl-3955 transfer set.The reported complaint can be confirmed based on the images provided; however, without the return of the sample and mating devices a probable cause cannot be determined.No other visible damage or anomalies are shown in the images provided.A dhr lot review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 46 CM (18") APPX 5.7 ML, PUR TRANSFER SET W/CHEMOLOCK ADDITIVE PORT, 0.2 MICRON
• 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: 11529411
• MDR Text Key: 256706178
• Report Number: 9617594-2021-00091
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: K131549
• 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: 03/11/2021

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: 011-CL3955
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOLUTION CONTAINER, MFR UNK.