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 Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplement medwatch report will be submitted upon the completion of this activity.

Event Description

The nurse at the user facility reported a blood loss event that occurred while a patient underwent a routinely scheduled hemodialysis (hd) treatment.The blood leak was visually observed 2 hours after initiation of the patient¿s hd therapy.The tubing disconnected from the bloodline, where the venous chamber connects to the transducer.The blood leak was noted as being very minor.The patient¿s estimated blood loss (ebl) was noted as being approximately 20 cc.No machine alarm was generated as it is not expected to do so.The patient completed treatment with a new setup on the same machine.There were no patient adverse effects experienced and no medical intervention was required as a result of this event.The complaint device is not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.However, a companion sample was returned to the manufacturer for analysis.

Manufacturer Narrative

The actual complaint device was not available for physical evaluation, however, thirty-five (35) companion samples from the same lot were returned to the manufacturer for investigation.A visual examination of the returned companion samples found the bloodlines to be acceptable.No defects or irregularities were observed or identified.A single companion sample was then tested using a 2008t hemodialysis machine for simulated use.During the simulated use test, there were no observations of a disconnection or a leak from the bloodline companion device.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 material and process controls were within specification.The lot passed all release criteria.The investigation into the cause of the reported problem was not 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 definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual complaint device.Therefore, the complaint has been deemed unconfirmed.

• 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: 6308378
• MDR Text Key: 66778167
• Report Number: 8030665-2017-00048
• Device Sequence Number: 1
• Product Code: FJK
• 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,Followup
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 16KR01410
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2016
• 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: 67 YR