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

Catalog Number 03-2962-3

Device Problem Air Leak (1008)

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

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.No further testing was done on a companion sample as the entire lot has been sold and distributed.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the actual 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 non-conformances or any associated rework identified during the manufacturing process which could be associated with the reported event.In addition, the lot passed all in-progress and final qc testing and passed all release criteria.The investigation into the cause of the reported problem was not able to confirm the failure mode.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.Therefore, the complaint has been deemed unconfirmed.

Event Description

A nurse reported that during a home hemodialysis (hd) patient's treatment, the patient reportedly observed air bubbles in the blood lines.Follow-up with the patient confirmed that sometime before the month of (b)(6), the 2008k@home machine alarmed for air detected approximately 3/4 of time into the hd treatment.The patient had ended treatment and started to do a manual return of his blood.The patient was able to return 3/4 of the blood within the extracorporeal circuit.The patient's estimated blood loss (ebl) was noted as being approximately 1/4 of the blood that was left in the circuit.The patient did not set up with new supplies to complete the rest of treatment.The patient was able to successfully complete his next scheduled treatment.There were no patient adverse effects and no medical intervention was required as a result of this event.The patient continues to have successful home hd treatments.No damage to the bloodline tubing set was visible.The bloodline complaint device is not available to be returned to the manufacturer as it was discarded by the patient.The machine alarmed for air appropriately.Recently, the patient's associated clinic sent a biomedical technician to the patient's home to verify the machine's operational integrity.Functional testing performed by the biomed confirmed the unit was operating properly.The machine passed all functional tests and remains in use by the patient.

• Brand Name: HOME HEMO 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 johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6086128
• MDR Text Key: 59466583
• Report Number: 8030665-2016-00559
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/08/2016

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: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 03-2962-3
• Device Lot Number: 16AR01291
• Other Device ID Number: 00840861100330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2016
• 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 2008K@HOME HEMODIALYSIS (HD) MACHINE