MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN DISPOSABLE DEVICE; INTRAVENOUS ADMINISTRATION TUBING EXTENSION SET

Catalog Number UNKNOWN

Device Problem Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 07/01/2023

Event Type  malfunction  

Event Description

The event occurred on an unspecified date and involved an unknown disposable device.The customer reported that they were informed of a problem of air embolism in a sickle cell anemia patient who was connected a pca device; the cassette was isolated and presented air in the circuit, with a question regarding the manipulation of the left jugular catheter.The customer reported that the patient went to a hyperbaric chamber in garches and was reported to be doing quite well recently.There was patient involvement; no harm was reported as a consequence of this event.

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.

Manufacturer Narrative

Additional information was received confirming that the device involved in this incident was not in fact an icu medical, inc product.The device involved in this incident is a legacy smith product and was reported under l-sm complaint (b)(4).Additional information in attachment section.

• Brand Name: UNKNOWN DISPOSABLE DEVICE
• Type of Device: INTRAVENOUS ADMINISTRATION TUBING EXTENSION 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: 17480243
• MDR Text Key: 321175748
• Report Number: 9617594-2023-00499
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PCA PUMP, MFR UNK