MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 43 CM (17") TRANSFER SET, PUR W/CLAVE¿, 10 UNITS; STOPCOCK, I.V. SET

Catalog Number 011-H1922-10

Device Problem Air/Gas in Device (4062)

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

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event involved a 43 cm (17") transfer set, pur w/clave¿, 10 units where it was reported the infusion took longer than the desired infusion time.During the infusion of paclitaxel, the nurses noticed decreased flow due to an "air occlusion" alarm was triggered, signaling the presences of air in the tubing.The line was primed to expel the air and infuse at the desired flow rate.The patient's condition was unchanged before and after the infusion and no medical intervention needed.There was no delay in therapy, just an extension of the infusion time, therefore a longer consultation for the patient.There was air present in the tubing, which afterwards was removed during priming.It is unknown if the reduction in flow was linked to the air in the tubing or after the pump has alarmed.There was patient involvement, however, no report of patient harm.

• Brand Name: 43 CM (17") TRANSFER SET, PUR W/CLAVE¿, 10 UNITS
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18949842
• MDR Text Key: 338365283
• Report Number: 9617594-2024-00315
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709123953
• UDI-Public: (01)00887709123953(17)280301(10)13558622
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H1922-10
• Device Lot Number: 13558622
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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: ALARIS ASENA GW PUMP; PACLITAXEL, UNK MFR