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 03-2722-9

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem Blood Loss (2597)

Event Date 07/26/2017

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A biomedical technician (biomed) at the user facility reported that a patient experienced blood loss while undergoing hemodialysis (hd) treatment.The following details were provided.The patient has been undergoing hd therapy three (3) times a week for one (1) month.The blood leak occurred where union and reducer pieces of the bloodline are fused together near the blood pump.It is unknown how much blood was loss.The treated was discontinued and the patient was taken to the hospital for evaluation.The bloodline product was not available to be returned to the manufacturer for evaluation.

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 labeling, 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.

• 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: 6796731
• MDR Text Key: 82768988
• Report Number: 8030665-2017-00581
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• 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: consumer,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 17BR01182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• 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 Outcome(s): Hospitalization; Required Intervention