MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IT; BIFURCATED MONITORING KIT W/03 ML FLUSH DEVICE, TRANSPAC® IT

Model Number 011-46110-48

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event occurred on an unspecified date in (b)(6) 2018.The customer reported the arterial tubing, before the three way stopcock, is detaching from the secure connector of the bifurcated monitoring kit resulting in a leak.The event occurred in the intensive therapy unit or operating theatre.The customer reported that there was minimal blood leakage as a result of the leak and the patient's blood pressure remained stable.There was no reported delay of critical therapy and no medical interventions required.There were no adverse operator consequences reported.The device was changed out with no further problems encountered.

Manufacturer Narrative

One (1) used partial bifurcated monitoring kit was received for testing.A separation was confirmed between the 83" pressure tubing and the male luer.The separated tubing showed signs of insufficient solvent.A same lot sample of a female luer on the opposite side of the 83" arterial tubing was pull tested and passed specification.A dhr review was completed and two (2) relevant non-conformities were noted.One non-conformity was due to four (4) pieces failing functional pull testing.The cause was attributed to insufficient solvent.Then 100% functional testing was conducted on the lot with 28 additional pieces found to be non-conforming.One other non-conformity found one piece that had a tubing separation during a movement and flexion test.Then 100% inspection was completed and 54 additional non-conformities were found.Icu medical, through continuous initiatives has initiated a multitask 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: TRANSPAC® IT
• Type of Device: BIFURCATED MONITORING KIT W/03 ML FLUSH DEVICE, TRANSPAC® IT
• 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: 7238340
• MDR Text Key: 99610192
• Report Number: 9617594-2018-00019
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/01/2020
• Device Model Number: 011-46110-48
• Device Catalogue Number: 011-46110-48
• Device Lot Number: 3509535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2018
• Patient Sequence Number: 1