PUREGRAFT 850 SYSTEM 101-014-02 850/PURE-INT

[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