MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-05-02 for PUREGRAFT 850 SYSTEM 101-014-02 850/PURE-INT manufactured by Puregraft Llc.
[143942563]
Instructions for use (600-014-02), includes instructions on how to operate the product. According to table 1, drain time is approximately 2-6 minutes, depending on the input volume. It is not known whether the clinician followed instructions in the ifu. It is also unknown whether the clinician opened the pinch clamp to allow successful draining. The device was not returned to the manufacturer for investigation. Photos were not provided. Puregraft personnel conducted in-house testing to simulate drain failure. The failure could not be replicated. Puregraft personnel also kinked the tubing; however, draining was still successful after kinking tubing and the failure could not be replicated. The lot history documentation was reviewed and no discrepancies or issues of non-conformance were noted. The device was manufactured to specifications. No further action is required. The root cause could not be identified. Puregraft will continue to monitor for recurrence.
Patient Sequence No: 1, Text Type: N, H10
[143942564]
During breast lipostructure surgery, the puregraft bag 850cc does not or very little filter the infiltration fluid, which led to the necessity of fat extraction and centrifugation of a part of the pocket. This resulted in difficulty in taking the fat out of the pocket. This led to extension of surgery time of 1h20, patient had hypothermia at 35. 5? C during surgery, which increased post-operative risk. Precautionary measures were taken: strict asepsis and antibioprophylaxis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011277972-2019-00001 |
| MDR Report Key | 8575792 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-05-02 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2018-07-01 |
| Date Added to Maude | 2019-05-02 |
| 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 | OLIVIA KIM |
| Manufacturer Street | 420 STEVENS AVE. SUITE 220 |
| Manufacturer City | SOLANA BEACH CA 92075 |
| Manufacturer Country | US |
| Manufacturer Postal | 92075 |
| Manufacturer Phone | 8583488050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUREGRAFT 850 SYSTEM |
| Generic Name | SYSTEM, SUCTION, LIPOPLASTY |
| Product Code | MUU |
| Date Received | 2019-05-02 |
| Model Number | 101-014-02 |
| Catalog Number | 850/PURE-INT |
| Lot Number | 00052114 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PUREGRAFT LLC |
| Manufacturer Address | 420 STEVENS AVE. SUITE 220 SOLANA BEACH, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-02 |