MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-02 for HOME HEMO COMBI SET FOR CANADA 03-2932-6 manufactured by Erika De Reynosa, S.a. De C.v..
[104266702]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.?
Patient Sequence No: 1, Text Type: N, H10
[104266703]
A user facility reported that the red clamp on the arterial line would not come undone at the end of a patient? S hemodialysis (hd) treatment. It was reported that the bloodline appeared to be cross-threaded. There were no visual issues reported on the primary or secondary packaging of the bloodline and no abnormalities observed on the clamp. It was reported that the patient lost a circuit of blood because the clamp was unable to be undone. The patient was able to complete treatment. There were no adverse events, injuries, or the necessity of medical intervention reported. The complaint device was discarded and is not available to be returned to the manufacturer for physical evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030665-2018-00478 |
| MDR Report Key | 7390420 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-02 |
| Date of Report | 2018-04-05 |
| Date of Event | 2017-11-30 |
| Date Mfgr Received | 2018-04-04 |
| Device Manufacturer Date | 2016-09-14 |
| Date Added to Maude | 2018-04-02 |
| 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 FOR CANADA |
| Generic Name | HEMODIALYSIS SYSTEM FOR HOME USE |
| Product Code | ONW |
| Date Received | 2018-04-02 |
| Catalog Number | 03-2932-6 |
| Lot Number | 16LR01800 |
| Device Expiration Date | 2018-05-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-04-02 |