MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER CF-250 manufactured by Charter Medical, Ltd..
[105756702]
The complaint sample was not returned to the manufacturer for investigation/review. However, a picture of the bag was forwarded by the user facility. The bag lot number, lot 150297, was visible from the picture. The picture indicated a bag with an open inlet tube and there was no visible evidence of a user applied seal on the inlet tube. The standard method of use for the cf-250 is for the user to fill the bag, apply a seal on the inlet tube, and discard the remaining un-needed tubing. The bag is then frozen. There are one of two potential scenarios: - the user's tube seal failed. - the tube broke below the user applied seal after the bag was frozen. The reported leak did not occur during filling of the bag or during the freezing process, which suggests the inlet tube break likely occurred after the bag was frozen. There was no additional information to suggest an exact root cause for this report. There are several potential issues which could contribute to a failure mode of this nature. - residual moisture on the outside of the bag when it was placed inside the cassette. Residual moisture could cause the inlet tube to freeze/adhere to the cassette during the freezing process. A condition of this type could cause tube damage upon removal of a frozen bag from the cassette. - handling of the bag in the frozen state. The film and inlet tube of a frozen bag is fragile - inadvertent manipulation or impact on the bag could cause the inlet tube to fracture. Precautions to help prevent issues indicated above are addressed in the product ifu's.
Patient Sequence No: 1, Text Type: N, H10
[105756703]
On (b)(6) 2018, after the technician thawed the bag containing autologous cell product, a leak was detected from a broken bag filler tube. A user sealed segment of the tube was detached from the bag. The technician clamped the remaining portion of the filler tube to prevent additional leaking. The bag initially contained approximately 60ml of cell product. The technician was able to recover 49ml of cell product, which was infused into a patient. Total cd34/kg cells infused was 2. 061 e6 instead of 2. 16 e6 cells that should have been infused.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2018-00008 |
| MDR Report Key | 7430635 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-11 |
| Date of Event | 2018-02-26 |
| Date Mfgr Received | 2017-03-13 |
| Date Added to Maude | 2018-04-13 |
| 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 | MS. JESSICA HUGHES |
| Manufacturer Street | 3948-A WESTPOINT BLVD. |
| Manufacturer City | WINSTON SALEM NC 27103 |
| Manufacturer Country | US |
| Manufacturer Postal | 27103 |
| Manufacturer Phone | 3367686447 |
| Manufacturer G1 | CHARTER MEDICAL, LTD. |
| Manufacturer Street | 3948-A WESTPOINT BLVD. |
| Manufacturer City | WINSTON SALEM NC 27103 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27103 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Generic Name | 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2018-04-13 |
| Model Number | CF-250 |
| Catalog Number | CF-250 |
| Lot Number | 150297 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHARTER MEDICAL, LTD. |
| Manufacturer Address | 3948-A WESTPOINT BLVD. WINSTON SALEM NC 27103 US 27103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-13 |