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

Catalog Number	03-2962-3
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were no non-conformances or abnormalities during the manufacturing process which could be associated with the reported event.In addition, the dhr review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all release specifications.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.
Event or Problem Description
A home hemodialysis (hd) therapies nurse reported that approximately three hours into hd treatment, the saline clamp on the fresenius bloodline had become un-clamped and caused saline to be introduced to the home hd patient.The home hd machine alarmed as expected for air detector and prevented air from being introduced to the patient.The patient's estimated blood loss (ebl) was noted as being approximately 300 ml (milliliters).The hd treatment was terminated two hours early.No patient adverse effects or injuries were experienced and no medical intervention was required.The patient has continued regularly scheduled hd therapy sessions without any further incidents.The bloodline device was not available to be returned to the manufacturer as it was discarded by the patient.

• 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: 6717767
• Report Number: 8030665-2017-00449
• Device Sequence Number: 10983094
• Product Code: ODX
• UDI-Device Identifier: 00840861100330
• UDI-Public: 00840861100330
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K070049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/17/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 03-2962-3
• Device Lot Number: 16DR01334
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008K@HOME HEMODIALYSIS MACHINE
• Patient Age: 55 YR
• Patient Weight: 211