MAUDE Adverse Event Report: GAMBRO DASCO S.P.A GAMBRO BLOODLINE ACCESSORIES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number Y CONNECTOR S-660-C

Device Problem Alarm Not Visible (1022)

Patient Problem Blood Loss (2597)

Event Date 10/05/2013

Event Type  malfunction  

Event Description

A patient in (b)(6) was three hours into a dialysis treatment when the nurse noticed a blood leak from the venous line on the y connector s-660-c.The estimated blood loss was 100 ml.Treatment was temporarily interrupted in order to replace the y connector s-660-c.The patient did not present with any clinical symptoms as a result of this event.

Manufacturer Narrative

The involved bloodline accessory is not available for investigation since it was discarded by the customer.Reportedly, a puncture was observed at the level of female luer-lock connector of the venous line on the y connector s-660-c.Retained samples from different lots were analyzed.No deviation or anomaly was identified.All y connectors s-660-c were found conforming to manufacturer specification.Analysis of the device history record and quality control data of the lot number belonging to this batch were manufactured and tested in accordance with specification.No same or similar defect was found in internal production.There were no nonconformities, no anomalies, no complaints for this lot (4.900 in the lot) or any other complaints from this product for any lot of 2.212.559 products produced.This was an isolated event.Technical analysis confirmed there was no defect or deviation in the mould process.During the manufacturing process, a leak test is performed, which would detect a leak and if detected, the part would be scrapped.The cause of this puncture can not be identified but it most likely was caused by the user.There is nothing that indicates this was due to a deviation in the product or in the manufacturing process.Gambro does not regard the submittal of this report as an admission of causation or liability.The involved bloodline accessory was discarded by the customer.

• Brand Name: GAMBRO BLOODLINE ACCESSORIES
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): GAMBRO DASCO S.P.A; via modenese 66; medolla I-410 36; IT I-41036
• Manufacturer Contact: via modenese 66; medolla ; 53550111
• MDR Report Key: 3573651
• MDR Text Key: 4076671
• Report Number: 9610270-2014-00001
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K801016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/10/2014,10/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: Y CONNECTOR S-660-C
• Device Catalogue Number: 101354
• Device Lot Number: 1323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2014
• Distributor Facility Aware Date: 10/11/2013
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2013
• Date Manufacturer Received: 10/11/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other