MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2008-09-02 for CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET R4R9955 manufactured by Baxter Healthcare Corporation - Mountain Home.
[909691]
The customer reported that a cryocyte freezing container split. The bag was ok when it was checked in the laboratory and was not dropped. The split occurred during handling prior to thawing. Volume of product frozen in this bag was 80ml. Cd34 selected cells were the types of cells stored in the bag. (b) (4). The nursing staff involved in this incident was adamant that the bag was not dropped. There have been no recent changes in protocol, critical equipment/supplies or personnel. Transplantation was performed in (b) (6) 2008. The clinicians were informed of the sterility testing showing positive for microorganisms. It is unknown to the customer if any additional antibiotics were given to the patient due to this event. The local complaint coordinator has indicated that there will be no further information available for this complaint.
Patient Sequence No: 1, Text Type: D, B5
[8195819]
(b) (4) evaluation summary: the evaluation confirmed the reported problem. Upon visual inspection, a yellow note was attached to the bag over the cracks ending approximately 2 1/4" from the top of the bag. The crack extended to the lower right end of the hanger hole through the end seal of the bag up to approximately 2 1/4" from the top of the bag. Major branching emanating from a single point are a strong indication of impact or additional mechanical stress on the bag at the point. The customer did not report any type of dropping or obvious mechanical stress that might have caused this breakage. However, review of procedural parameters provided by the customer indicated that a protective cassette is not used for storage in vapor phase. Cryocyte freezing container labeling does recommend the use of a protective cassette for storage. It is not possible to confirm a root cause for this rupture. A review was performed on all batch record documents for the lot number involved, finding no issues during the manufacturing process or deviation from standard procedure. In addition, all units are 100% pressure tested during the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00784 |
| MDR Report Key | 1149544 |
| Report Source | 01,06 |
| Date Received | 2008-09-02 |
| Date of Report | 2008-06-26 |
| Date of Event | 2008-06-16 |
| Date Mfgr Received | 2008-06-26 |
| Device Manufacturer Date | 2006-12-04 |
| Date Added to Maude | 2009-12-31 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY, MANAGER |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | 1900 HIGHWAY 201 NORTH |
| Manufacturer City | MOUNTAIN HOME AR 72653249 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 2497 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET |
| Generic Name | 81KSE |
| Product Code | KSE |
| Date Received | 2008-09-02 |
| Returned To Mfg | 2008-07-03 |
| Catalog Number | R4R9955 |
| Lot Number | H06L01032 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION - MOUNTAIN HOME |
| Manufacturer Address | MOUNTAIN HOME AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-02 |