MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. HOME HEMO COMBI SET; AUTONOMOUS EXTRACORPOREAL BLOOD LEAK DETECTOR/ALARM

Model Number	03-2962-3
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: although a companion sample was reported to be available for manufacturer evaluation, to date no sample has been received.As the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should the sample be returned at a later date, a supplemental report will be submitted capturing the updated investigation results.
Event or Problem Description
A patient¿s contact reported to customer service (cs) that a combi set blood leak occurred at the beginning of the patient¿s hemodialysis (hd) treatment.During follow up, the contact had a difficult time explaining where the leak was coming from.In addition, the contact wasn¿t exactly sure of the leak origin.The blood loss was reported to be minimal; the contact estimated ¿one or two spoonfuls¿ of blood loss.No damage was identified on the product, and there were no machine alarms.The contact reportedly clamped the line that was leaking, and successfully stopped the leak.Afterwards, the patient completed their treatment using the same supplies.The contact stated there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.Additional information was obtained during follow up with the clinic manager (cm) at the patient¿s user facility.The cm confirmed the patient hadn¿t experienced any adverse effects, and that medical intervention was not required.The details of the event were not entirely clear to the cm.As they understood it, the leak was coming from the heparin line as the patient's contact was administering a heparin bolus.Per the cm, the heparin line needs to be clamped when this process is occurring.The cm was skeptical that the line was properly clamped at the time of the event.No further details were provided.The combi set was reportedly discarded after use.A companion sample was reported to be available for evaluation.

• Brand Name: HOME HEMO COMBI SET
• Common Device Name: AUTONOMOUS EXTRACORPOREAL BLOOD LEAK DETECTOR/ALARM
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 9935646
• Report Number: 8030665-2020-00419
• Device Sequence Number: 2497569
• Product Code: ODX
• UDI-Device Identifier: 00840861100330
• UDI-Public: 00840861100330
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K070049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: 03-2962-3
• Device Catalogue Number: 03-2962-3
• Device Lot Number: 19ER01238
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 78