MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IV MONITORING KIT WITH SAFESET; TRANSPAC® IV MONITORING KIT WITH SAFESET¿

Model Number 01C-42640-06

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned to the manufacturer for investigation.It has not been received.

Event Description

The event involved a customer report that a transpac tubing set was disconnected/broken between the pressure line and the blood withdrawal port during priming with heparinized saline.It was reported that the device as replaced with no further problems reported.There was no adverse event or delay in critical therapy reported.

Manufacturer Narrative

One (1) used partial set 01c-42640-06 transpac® iv monitoring kit with safeset¿ reservoir was received for testing.Testing found a tubing separation in the 27" arterial pressure tubing and the safeset port.The cause was insufficient solvent bond on the tubing.A device history review (dhr) was completed and no relevant non-conformities were noted.The reported complaint of tubing breakage or separation was confirmed.The cause of the separation was due to insufficient solvent.

• Brand Name: TRANSPAC IV MONITORING KIT WITH SAFESET
• Type of Device: TRANSPAC® IV MONITORING KIT WITH SAFESET¿
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• MDR Report Key: 7629792
• MDR Text Key: 112566813
• Report Number: 9617594-2018-00038
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619037475
• UDI-Public: 840619037475
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: 01C-42640-06
• Device Catalogue Number: 01C-42640-06
• Device Lot Number: 3550279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2018
• Patient Sequence Number: 1
• Treatment: HEPARINIZED SALINE; PHILLIPS MONITOR