MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 1 SAFESET¿, 1 TRANSDUCER 1 PORT, 53 INCH (134 CM), 3ML/ HR MACRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-0P261-01

Device Problem Material Separation (1562)

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

Event Date 01/01/2022

Event Type  malfunction  

Event Description

The event occurred on an unspecified date.The customer reported that over the past few days they had several incidents with 1 safeset¿, 1 transducer 1 port, 53 inch (134 cm), 3ml/ hr macrodrip, either right out of the packaging or a few days after use.The lines split (drop by drop) just above the rinsing site.The status of the product at the time of event right out of the packaging and few days after use.There was no patient involvement, no adverse event or human harm.

Manufacturer Narrative

The location of the device is unknown.

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed and there were no nonconformities which would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.The reported complaint cannot be confirmed.

• Brand Name: 1 SAFESET¿, 1 TRANSDUCER 1 PORT, 53 INCH (134 CM), 3ML/ HR MACRODRIP
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 13472145
• MDR Text Key: 286450582
• Report Number: 9617594-2022-00016
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619028527
• UDI-Public: (01)00840619028527(17)240701(10)5509061
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

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: 011-0P261-01
• Device Lot Number: 5509061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 02/24/2022
• Supplement Dates FDA Received: 03/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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