MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-07 for COLLECTIVE CONCENTRATE- GRANUFLO UNKNOWN- CONCENTRATE- GRANUFLO manufactured by Corporate.
[174079473]
Clinical review: a possible temporal, causal and/or contributory relationship exists between the alleged patient use of granuflo acid concentrate during hd therapy in 2015, and the serious adverse event of death. However, there is no ability to confirm the event, nor obtain treatment records for the alleged death with granuflo use. Additionally, there is no documentation in the complaint file identifying when and where the alleged event occurred. The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population. Based on the limited information available, it cannot be determined if the use of the granuflo acid concentrate caused or contributed to the reported death of this patient. 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
[174079474]
A (b)(6) social media post was found which documented a hemodialysis (hd) patient expired (date not provided) after using granuflo acid concentrate. The patient contact alleged that the granuflo was recalled, however it was administered to the patient. There was no contact, patient, or product information provided. Additional information is unable to be obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1225714-2020-00001 |
| MDR Report Key | 9560171 |
| Report Source | CONSUMER |
| Date Received | 2020-01-07 |
| Date of Report | 2020-02-24 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-01-07 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 4040 NELSON AVENUE |
| 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 | 2020-01-07 |
| 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 4040 NELSON AVENUE WALTHAM MA 02451 US 02451 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-07 |