MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-10-14 for CRYOCYTE PACK R4R9953 manufactured by Baxter Healthcare - Mountain Home.
[15361732]
A customer informed us that he observed? Exploding closure caps? Of (old) cryocyte bags, code r4r9953, and that he is therefore, not able to retrieve the frozen product under sterile conditions. No batch numbers, quantities, or any other information communicated so far. Customer first contacted miltenyi (former distributor of cryocyte bags), but they told that they are not responsible.
Patient Sequence No: 1, Text Type: D, B5
[15765991]
Complaint no: (b)(4). Baxter medical assessment: this is a cryocyte bag breakage that was discovered. There have been no reported negative clinical consequences for the patient. As in all cases of cryocyte bag breakages during storage there is the potential of loss of engraftment or delay in engraftment with the loss of product. This puts the patient at greater risk. As such, a breakage could potentially cause or contribute to an adverse event if it were to reoccur. Please know this product is end of life. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[22228249]
(b)(4). Baxter mountain home completed the investigation. As neither sample nor batch number are available, a sample evaluation and batch review could not be performed. Units were 100% inspected pre-sterilization by production during the manufacturing process. No batch number received therefore, no results of inspections could be reviewed. This product is in the end of life proceedings and is no longer manufactured. No trend is identified. ---------- the complainant reported a cryocyte bag rupture that is consistent with breakage investigated in a corrective and preventive action record (capa# (b)(4)). (b)(4) was initiated to address this issue. As a result of multiple analyses, the two contributing root causes were identified as: 1) nitrogen ingress through the ports resulting in breakage when nitrogen gas expands during thawing leading to a brittle fracture, and 2) customer usage variability. The following process improvements were initiated: 1) minimizing manufacturing variability through "mistake proofing", and 2) minimizing customer usage variability by clarifying the "instructions for use" through label copy improvements. However, it must be noted that routine complaint monitoring has revealed a decrease in the field complaint rate before any actions were implemented. (b)(4) was closed on january 28, 2009. Complaint monitoring has been conducted to identify complaints for lots produced post corrective action. This product is end of life. This case will be kept on file for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2014-35840 |
| MDR Report Key | 4171346 |
| Report Source | 01,05 |
| Date Received | 2014-10-14 |
| Date of Report | 2014-10-04 |
| Date of Event | 2014-10-04 |
| Date Mfgr Received | 2014-10-31 |
| Date Added to Maude | 2014-10-27 |
| 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 | KIMBERLY CRANE |
| Manufacturer Street | ONE BAXTER WAY |
| Manufacturer City | WESTLAKE VILLAGE CA 91362 |
| Manufacturer Country | US |
| Manufacturer Postal | 91362 |
| Manufacturer Phone | 8053723182 |
| Manufacturer G1 | BAXTER HEALTHCARE - MOUNTAIN HOME |
| Manufacturer Street | 1900 N HIGHWAY 201 |
| Manufacturer City | MOUNTAIN HOME AR 72653 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOCYTE PACK |
| Generic Name | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS |
| Product Code | KSR |
| Date Received | 2014-10-14 |
| Catalog Number | R4R9953 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - MOUNTAIN HOME |
| Manufacturer Address | 1900 N HIGHWAY 201 MOUNTAIN HOME AR 72653 US 72653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-14 |