MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-07-17 for HOME HEMO COMBI SET 03-2962-3 manufactured by Erika De Reynosa, S.a. De C.v..
[80219418]
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.
Patient Sequence No: 1, Text Type: N, H10
[80219419]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2017-00449 |
| MDR Report Key | 6717767 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-17 |
| Date of Report | 2017-07-17 |
| Date of Event | 2017-06-19 |
| Date Mfgr Received | 2017-06-22 |
| Device Manufacturer Date | 2016-04-26 |
| Date Added to Maude | 2017-07-17 |
| 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 | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Street | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA |
| Manufacturer City | REYNOSA 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 | AUTONOMOUS EXTRACORPOREAL BLOOD LEAK DETECTOR/ALARM |
| Product Code | ODX |
| Date Received | 2017-07-17 |
| Catalog Number | 03-2962-3 |
| Lot Number | 16DR01334 |
| Device Expiration Date | 2019-04-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ERIKA DE REYNOSA, S.A. DE C.V. |
| Manufacturer Address | MIKE ALLEN #1331 PARQUE INDUSTRIAL REYNOSA REYNOSA 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-17 |