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 Problem Fluid/Blood Leak (1250)

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

Event Date 10/11/2016

Event Type  malfunction  

Manufacturer Narrative

The user facility returned a single case, which contained 22 companion device samples, to the manufacturer for physical evaluation.A visual examination of all returned device samples found the bloodline blood sets to be acceptable; no defects identified.One companion sample was then tested using a 2008t hemodialysis machine for simulated use.During the simulated use test, fluid flowed through the lines without issue and there were no observations of a leak.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.The device history record [dhr] of this product was reviewed and no nonconformance reports or other abnormalities during the assembly of this lot were found.The product involved met specifications.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.

Event Description

A user facility reported that a blood leak occurred immediately after initiation of the patient's hemodialysis (hd) treatment.The machine alarmed and blood was observed externally leaking from the medication port of the bloodline.No damage was observed to the bloodline.The patient's estimated blood loss (ebl) was noted as being approximately 200cc.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient completed treatment with a new set-up on the same machine.The complaint device is not available to be returned to the manufacturer for evaluation as it was discarded by the user facility.However, companion samples are available and will be returned for a manufacturer evaluation.

• 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: 6083430
• MDR Text Key: 59342441
• Report Number: 8030665-2016-00557
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/07/2016

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: 04/30/2019
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 16DR01310
• Other Device ID Number: 00840861100293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2016
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• 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
• Treatment: FRESENIUS 2008T HEMODIALYSIS MACHINE
• Patient Age: 59 YR
• Patient Weight: 108