MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC TRIFURCATED MONITORING KIT, 60" TUBING, 3 3 ML FLUSH DEVICE, MICRODRIP; TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT

Catalog Number 011-0J988-01

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned.The device is not yet received.

Event Description

The customer reported two transpac trifurcated monitoring kits that during priming, part of the pressure line disconnected where it should have been bonded to.There were no additional information provided.There was no patient involvement and no patient harm.This is the first of two events reported.

Manufacturer Narrative

D10: date returned to manufacturer is 9/16/2020.H10: one (1) used partial list # 011-0j988-01, transpac¿ trifurcated monitoring kit, 60" tubing, 3 3 ml flush device, microdrip; lot # 3964739 was received for evaluation.The reported complaint of disconnection was confirmed on the returned set.During visual inspection, the 60" pressure tubing was received broken from the winged male luer.The winged male luer was not received for evaluation.It is unknown how and when the tubing breakage had occurred.The packaging was observed and no indentation was observed which could lead to the to the reported complaint.The returned trifurcated monitoring set was primed and pressure leak tested and no leaks were observed.The probable cause for the broken pressure tubing is unknown.

• Brand Name: TRANSPAC TRIFURCATED MONITORING KIT, 60" TUBING, 3 3 ML FLUSH DEVICE, MICRODRIP
• Type of Device: TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
• 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: 10534624
• MDR Text Key: 206949733
• Report Number: 9617594-2020-00394
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619030032
• UDI-Public: (01)00840619030032(17)220101(10)3964739
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 011-0J988-01
• Device Lot Number: 3964739
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IV FLUIDS, BAXTER; IV FLUIDS, BAXTER