MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 01C-42584-05

Device Problem Separation Problem (4043)

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

Event Date 03/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Initial reporter phone is (b)(6).

Event Description

The event involved a transpac iv monitoring kit where it was reported that a clinician found the pressure line separated when taking out of package.The device was changed out/replaced with no further problems encountered.There was no patient involvement, no adverse event and no delay in critical therapy.

Manufacturer Narrative

No product samples, videos were returned for investigation.The reported complaint of separation was confirmed.However an image was provided by the customer showing a tubing separation.Although an image was provided, without the return of the device, a probable cause could not be identified.The lot history was reviewed and there were no nonconformities which would have contributed to the reported complaint.Additional information: a5 - ethnicity and a6 - race.

• Brand Name: TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR
• 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: 14732260
• MDR Text Key: 294263380
• Report Number: 9617594-2022-00178
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619035730
• UDI-Public: (01)00840619035730(17)240401(10)5276631
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: 01C-42584-05
• Device Lot Number: 5276631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• 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