MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-11 for HOME HEMO COMBI SET 03-2962-3 manufactured by Reynosa Plant.
[40435369]
(b)(4) plant investigation is in process. A supplemental mdr will be submitted upon the completion of this activity.
Patient Sequence No: 1, Text Type: N, H10
[40435370]
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.
Patient Sequence No: 1, Text Type: D, B5
[44794892]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030665-2016-00116 |
| MDR Report Key | 5495729 |
| Date Received | 2016-03-11 |
| Date of Report | 2016-04-27 |
| Date of Event | 2016-02-20 |
| Date Mfgr Received | 2016-04-05 |
| Device Manufacturer Date | 2015-09-23 |
| Date Added to Maude | 2016-03-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CNOR TANYA TAFT |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999000 |
| Manufacturer G1 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA, TAMAULIPAS CP 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOME HEMO COMBI SET |
| Generic Name | HIGH PERMEABILITY HEMODIALYSIS SYSTEM FOR AT HOME USE |
| Product Code | ONW |
| Date Received | 2016-03-11 |
| Catalog Number | 03-2962-3 |
| Lot Number | 15LR01332 |
| ID Number | 00840861100330 |
| Device Expiration Date | 2018-09-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REYNOSA PLANT |
| Manufacturer Address | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA, TAMAULIPAS CP 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-11 |