MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2013-06-05 for HOME HEMO COBMI SET 03-2962-3 manufactured by .
[3546098]
It was reported by the user facility that during home hemodialysis pt education regarding the tightening of all bloodline connections during the set-up procedures, particularly the transducer protectors, one of the pts (identity unk) experienced a saline leak following treatment at the completion of re-transfusion. There was no blood loss or the need for medical intervention of any type during or following this event. There was no report of a serious injury.
Patient Sequence No: 1, Text Type: D, B5
[10812974]
Investigation is currently on going. A supplemental report will be submitted when complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030665-2013-00354 |
| MDR Report Key | 3159343 |
| Report Source | 04,05,06 |
| Date Received | 2013-06-05 |
| Date of Report | 2013-05-06 |
| Date of Event | 2013-05-06 |
| Date Mfgr Received | 2013-05-06 |
| Date Added to Maude | 2013-06-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CORIE VAZQUEZ |
| Manufacturer Street | 920 WINTER ST. POST MARKET CLINICAL |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999071 |
| Manufacturer City | REYNOSA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOME HEMO COBMI SET |
| Product Code | ODX |
| Date Received | 2013-06-05 |
| Catalog Number | 03-2962-3 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-05 |