MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-14 for 80-190 ML FILL VOLUME CRYOGENIC STORAGE CONTAINER CF-750 manufactured by Charter Medical, Ltd..
[82937277]
Four unused bags and three used bags were returned for investigation. No issues were observed on the unused bags. The bags were not used in a clinical setting. Irregular film fractures were observed on each of the three used bags. The film fractures were located on one side of all three returned used bags. The location and nature of the fractures suggested air bubbles may have been introduced into the bag when filling with fluid. The user provided pictures of cf-750 bags with fluid prior to freezing. Large bubbles were observed inside the bags. The bubbles inside the bags would correspond to the approximate area where the bag fractures were located on the three returned bags. There are other causes that could potentially result in bag fractures: - overfilling the bag. An overfilled bag could create resistance during insertion and removal of the bag from the metal cassette. - moisture on the exterior surface of the bag or cassette interior when the bag is inserted into the metal cassette. Moisture may cause the bag film to freeze to the interior cassette surface, thus potentially resulting in damage when the frozen bag is removed from the cassette. - an unknown material anomaly. The product instruction for use sheet is provided with each cf-750 device. Review of the ifu version provided with lot 149522 has the following precautions: - "port tubes and film are fragile in the frozen state and breakage may occur. Handle with care. " - "do not overfill. " - "remove as much air as possible from the container. " - "ensure bag exterior and protective freezing cassettes are dry prior to initiating freezing protocol. Moisture on exterior of bag or on cassette could cause adherence of bag to cassette resulting in difficulty of bag removal. "
Patient Sequence No: 1, Text Type: N, H10
[82937278]
The bags were placed in ln2 on (b)(6). The cracks were discovered when the bags were removed from the ln2 tank prior to thawing on (b)(6). There was no contact with a patient following discovery of the bag breaks. There was no injury, death or further medical intervention required as a result of this occurrence. There was no medical staff exposure as a result of this occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066733-2017-00008 |
| MDR Report Key | 6791907 |
| Date Received | 2017-08-14 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-07-06 |
| Date Mfgr Received | 2017-07-12 |
| Device Manufacturer Date | 2017-05-23 |
| Date Added to Maude | 2017-08-14 |
| 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 | 80-190 ML FILL VOLUME CRYOGENIC STORAGE CONTAINER |
| Generic Name | 80-190 ML FILL VOLUME CRYOGENIC STORAGE CONTAINER |
| Product Code | LPZ |
| Date Received | 2017-08-14 |
| Returned To Mfg | 2017-07-14 |
| Model Number | CF-750 |
| Catalog Number | CF-750 |
| Lot Number | 149522 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-08-14 |