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

Model Number 011-46113-62

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during priming, the bonding of the stopcock was disconnected, bad, or not bonded.Additionally, the customer stated that the line at the patient has been broken because of bad gluing.There were no reported adverse patient effects and no reported delay of critical therapy.

Manufacturer Narrative

One (1) 011-46113-62 monitoring kit was received for evaluation.Testing found the 52" arterial tubing was separated from the male luer.There appears to be insufficient solvent on the end of the tubing.A device history record (dhr) review was completed and no non-conformities were noted.The reported complaint of bonding separation near the stopcock was confirmed.This was due to insufficient solvent.

Manufacturer Narrative

Subsequent to medwatch follow-up 1, review of testing found there was sufficient solvent on the end of the tubing, instead of the reported insufficient solvent.The cause for the separation could not be determined.

• Brand Name: TRANSPAC IV
• Type of Device: TRANSPAC® IV MONITORING KIT W/SAFESET¿ RESERVOIR
• 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: 7367111
• MDR Text Key: 103673223
• Report Number: 9617594-2018-00033
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: 011-46113-62
• Device Catalogue Number: 011-46113-62
• Device Lot Number: 3506609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Patient Sequence Number: 1