MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SINGLE TRANSPAC® IT MONITORING KIT

Model Number 011-46112-28

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/25/2017

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not complete.

Event Description

The event involved (b)(6) unspecified incidents that occurred between (b)(6) 2017 and (b)(6) 2018.The customer reported that the pressure tube from the pressurized inlet disconnected.There were no reported adverse patient effects and no reported delay of critical therapy.No additional information was provided.

Manufacturer Narrative

Two (2) used partial transpac it sets with lot# 3451008 were evaluated.There was an arterial tubing separation between the 79.5" tubing and the female luer.An incomplete solvent ring was observed around the end of the tubing indicating the tubing had inadequate solvent.The female luer on the other end of the 79.5" tubing was pull tested and passed specifications.Five (5) representative samples of the same lot were functionally tested and all samples met specifications.A device history record (dhr) was completed on the final assembly, sub assembly and relevant molded parts and no relevant non-conformities were noted.Icu medical, through continuous initiatives has initiated a multi-task team and reviewed the assembly process of this subassembly.Subsequent to the initial medwatch report, manufacturing site was updated to reflect the legal manufacturing address instead of the address of the contact office.

• Brand Name: SINGLE TRANSPAC® IT MONITORING KIT
• Type of Device: SINGLE TRANSPAC® IT MONITORING KIT
• 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
• Manufacturer (Section G): ICU MEDICAL, INC.; 600 n. field drive, bldg h2-2n; lake forest IL 60045
• Manufacturer Contact: regina rose ; 951 calle amanecer; san clemente, CA 92673 ; 2247062300
• MDR Report Key: 7231938
• MDR Text Key: 98762466
• Report Number: 9617594-2018-00009
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Model Number: 011-46112-28
• Device Catalogue Number: 011-46112-28
• Device Lot Number: 3451008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1