MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2742-9

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the material and process controls were within specification.The lot passed all release criteria.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.

Event Description

A nurse at the user facility reported that a bloodline blood leak occurred approximately 2 hours after initiation of the patient¿s hemodialysis (hd) treatment.Blood leaked from the venous access port which the complainant reported was defective.Reportedly, when the cap was removed to attach a syringe for medication administration, blood leaked from the port.The 2008t hd machine did not generate an alarm as it was not expected to for an external leak.No damage was observed to the bloodline or its packaging.The patient completed the hd therapy on the same machine with the same setup.No patient adverse effects were experienced and no medical intervention was required as a result of this event.A blue hemosafe was applied to ensure that the port remained closed.A fresenius dialyzer was in use during the patient¿s hd treatment.The bloodline complaint device was not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.

• Brand Name: CUSTOM COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6726340
• MDR Text Key: 80512966
• Report Number: 8030665-2017-00456
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 17DR01147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 70