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 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

Event Description

The event involved transpac iv monitoring kit in which the customer reported ¿line separation.¿ the event occurred during patient infusion.The device was changed out/ replaced with no further problems encountered.There was patient involvement but no harm was reported as a consequence.This is report 1 of 2.

Manufacturer Narrative

The reported complaint of separation was confirmed.No product samples, videos were returned for investigation.However an image was provided by the customer showing the pvc tubing separated from the winged male luer.Without the return of the reported sample, 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.

• 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
• MDR Report Key: 12489328
• MDR Text Key: 274790215
• Report Number: 9617594-2021-00260
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619035730
• UDI-Public: (01)00840619035730(17)231201(10)5108662
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

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 Expiration Date: 12/01/2023
• Device Catalogue Number: 01C-42584-05
• Device Lot Number: 5108662
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1