MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-10 for COLLECTIVE CONCENTRATE- GRANUFLO UNKNOWN- CONCENTRATE- GRANUFLO manufactured by Corporate.
[178501708]
Clinical investigation: there is a possible temporal and causal relationship between the alleged incorrect mixing of the granuflo concentrate by a nurse and the death of this unidentified patient during hemodialysis. However, there is no ability to confirm the event or to obtain treatment records for the alleged death with granuflo use. There is no documentation in the complaint file of an event date or clinic location that this alleged event took place. The allegation was in a (b)(6) social media post. The granuflo concentrate instructions for use (ifu) warm about the failure to follow the instructions properly and the possibility of patient harm if not followed. The ifu gives instructions for the proper mixing of the concentrate. Based on the limited information available, it cannot be determined if the use of the alleged incorrectly mixed granuflo concentrate caused or contributed to any patient adverse event. Plant investigation: plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained. As a serial number could not be determined, device history and manufacturing records could not be reviewed. As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[178501709]
A (b)(6) social media user reported that a nurse "killed five patients" a couple of years ago by mixing granuflo incorrectly. No additional information was documented, and no contact information was obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1225714-2020-00003 |
| MDR Report Key | 9691015 |
| Report Source | CONSUMER |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-19 |
| Date of Event | 2016-01-01 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW AMARAL |
| Manufacturer Street | 920 WINTER ST |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999758 |
| Manufacturer G1 | CORPORATE |
| Manufacturer Street | 920 WINTER STREET |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLECTIVE CONCENTRATE- GRANUFLO |
| Generic Name | DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) |
| Product Code | KPO |
| Date Received | 2020-02-10 |
| Catalog Number | UNKNOWN- CONCENTRATE- GRANUFLO |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORPORATE |
| Manufacturer Address | 920 WINTER STREET WALTHAM MA 02451 US 02451 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-10 |