MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED STOPCOCK I.V. SET; STOPCOCK, I.V. SET

Catalog Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problems Burning Sensation (2146); Chemical Exposure (2570)

Event Date 08/25/2021

Event Type  malfunction  

Event Description

The event involved a 53 cm (21") set di sommin.Ambrato per pompa a 5 vie con camera iv2 that the customer reported a leak of methotrexate from the varoli valve on the infusion set during infusion on a patient.Iv therapy was administered according to the following scheme: 1) vincristine sulfate 2 mg in 20 ml of 0.9% nacl (duration 5 minutes); 2) cyclophosphamide 308 mg in 500 ml of nacl 0.9% (expected duration 60 minutes); 3) methotrexate 152 mg in 100 ml of nacl 0.9% (duration expected 30 minutes) and 4) methotrexate 1372 mg in 500 ml of nacl 0.9% (expected duration 23 hours and 30 minutes).At about 11:30 pm, spreading of methotrexate (1372 mg in 500 ml of nacl 0.9% from bag nâ° 4) was observed at the site and along the line (with a few drops falling to the ground).The operator detected complete filling of the underlying drip chamber on the infusion line and complete filling of the present chamber on the infusion set (from which the drug came out) at the same time.(b)(6).The device was in use at the time of the event and it was the first use.As a result, both line patency (did not present bottlenecks) and the proper functioning of the infusion pump needed to be verified.Implementations were made as required by the internal procedures of the facility in relation to the management of extravasations or spills of chemotherapy.The infusion line needed to be replaced with a consequent delay in the administration of therapy to the patient and also a loss of drug solution that could not be quantified accurately.In addition to the impact on the patient, the customer reported a burden for the department on the routine.In addition, the health care provider who managed the spread of chemotherapy was reported to have experienced ocular burning and required a visit to a specialist in the emergency room department.There was patient and health care provider involvement, unprotected exposure to chemotherapy, a delay in therapy and no human harm.

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not yet been received.

Manufacturer Narrative

The following was received by the customer: one used list# unknown chemoclave bag spike, lot # unknown.One used list #unknown, trifuse infusion set with drip chamber; lot #unknown.One used list #unknown, baxter sodio cloruro 0,9% baxter 100 ml intravenous bag; lot #21a25e1a.One used list #unknown, fresenius kabi sodio cloruro 100 ml container; lot #19qe8160.Sodium chloride residuals were observed in the returned device and mating devices.The device does not match the list # reported by the customer and recorded on the complaint record.The customer was unable to provide any additional information to confirm the specific list and lot number of the device in question.No visual damages observed.The air filter on the hydrostatic valve of the trifuse set appeared to have fluid coming out.The returned sets were leak tested and a leak was observed from the air filter on the top of the hydrostatic valve.The complaint of leakage can be confirmed on the returned device.The probable cause of the leakage through the air filter is unknown.Additional entries can be found in a5 and a6.Date returned to mfg: 11/4/2021.Updated information can be found in d1, d4, g4, h4 and h6 component code.

• Brand Name: UNSPECIFIED STOPCOCK I.V. SET
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 12614485
• MDR Text Key: 283407939
• Report Number: 9617594-2021-00277
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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: 0.9% NACL, UNK MFR; CYCLOPHOSPHAMIDE, MFR UNK; METHOTREXATE, MFR UNK; UNSPECIFIED INFUSION PUMP, MFR UNK; VINCRISTINE SULPHATE, MFR UNK
• Patient Age: 60 YR