MAUDE Adverse Event Report: REYNOSA PLANT HOME HEMO COMBI SET; HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE

Catalog Number 03-2962-3

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem Blood Loss (2597)

Event Date 02/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) plant investigation is in process.A supplemental mdr will be submitted upon the completion of this activity.

Event Description

A nurse reported that a blood leak occurred during a home hemodialysis treatment.Reportedly, the patient awoke approximately 1.5 hours into the treatment and observed a blood leak at the connection between the syringe that holds the heparin and the heparin line from the blood line.The connection was noted as being "not secure." the heparin pump continued to infuse and no alarms were generated during this event.The patient's estimated blood loss was approximately 50ml.No patient complications occurred as a result of this event and no intervention was required.The patient was able to continue dialyzing with new supplies and successfully complete the treatment using the same machine.The device is not available for evaluation by the manufacturer.

Manufacturer Narrative

The reported complaint is 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 manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lot passed all release criteria.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.

• Brand Name: HOME HEMO COMBI SET
• Type of Device: HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE
• Manufacturer (Section D): REYNOSA PLANT; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5495729
• MDR Text Key: 40435369
• Report Number: 8030665-2016-00116
• Device Sequence Number: 1
• Product Code: ONW
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

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: 09/30/2018
• Device Catalogue Number: 03-2962-3
• Device Lot Number: 15LR01332
• Other Device ID Number: 00840861100330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 03/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• 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: 59 YR
• Patient Weight: 75