MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED INTRAVENOUS TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problem Failure to Deliver (2338)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The event occurred on an unspecified date and involved an unspecified intravenous v tubing that had reportedly been causing occlusion errors - primarily proximal, but also some distal alarms; the alarms were seen where the cassette tests won't pass.It was not reported whether or not there was patient involvement; no harm was reported as a consequence of this event.

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.

Manufacturer Narrative

The complaint of an alarm could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.Device history review could not be reviewed due to the unknown lot number.

• Brand Name: UNSPECIFIED INTRAVENOUS TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 17725729
• MDR Text Key: 323309403
• Report Number: 9617594-2023-00685
• 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: US
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• 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