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

Catalog Number 03-2622-3

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

The complaint device was not returned for analysis; however, companion samples from the distribution center were made available to the manufacturer for physical evaluation.A visual examination was performed on the tubing set of one companion sample; no defects were identified.One companion sample was then tested using a 2008t hemodialysis machine for simulated use.The bloodline was able to be primed with no visible issues.During the simulated use test, fluid flowed through the lines without issue.There were no observations of a leak or separation from the main line tubing to the venous din connector.The device worked as intended with no noted abnormalities and no defects identified.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.The investigation into the cause of the reported problem was able to confirm the failure mode.Although the evaluation of the companion sample confirmed that the device functioned fully as designed and met specification, a picture was received from the customer confirming the separation from the main line tubing to the venous din connector.Therefore, the complaint has been deemed confirmed.

Event Description

A registered nurse (rn) at the user facility reported that a patient experienced blood loss while undergoing hemodialysis (hd) treatment.The following details were provided.The patient had been undergoing hd therapy three (3) times a week for two (2) years and four (4) months.Twenty minutes after initiation of hd therapy on (b)(6) 2017, a blood leak was observed on the venous line which screws into the venous head of the dialyzer.The estimated blood loss (ebl) was approximately six (6) milliliters (ml).There was no patient adverse reaction and no medical intervention required as a result of this event.The defective bloodline was not used to complete the treatment.There was no allegation that a dialyzer malfunction occurred.The bloodline product was not available to be returned to the manufacturer for evaluation.

• Brand Name: 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: 6770101
• MDR Text Key: 81920640
• Report Number: 8030665-2017-00537
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 17BR01045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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
• Treatment: UNKNOWN DIALYZER