MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2009-07-13 for TISSUE CULTURE FLASK R4R2110 manufactured by Baxter Healthcare.
[20997211]
This is an event report received on 24-jan-2009 about one unit of leaking life cell tissue culture bag, lot h08d14062, from a healthcare professional of the lab in hospital. Bone marrow material was donated on the morning of approx five months later, filled into three bags and forwarded to stemcells lab/tissue typing lab in another country's hospital, arriving in the lab the same day, respecting the transportation requirements for products of this type. During preparation for shipment, no leak was detected. The lab informed the reporter about a leak detected in one out of the three bags prior to filtration and reported as follows: "we got three bags with marrow from a donor, collected at your center that month. When we pooled the bags to take some samples, we found a small split in the upper corner of the bag where the seal of the plastic is. During the transport, it didn't leak. Pictures are taken and attached. We can't see any lot on the lifecell-bag but on the label the "unique identifier" is printed. The bags are saved here. " the pooled marrow from all three bags was transplanted, it is currently unknown if an antibiotic therapy was administered. Additional information received by baxter on 29-jun-2009: patient's condition after transplantation: she had difficulties to breathe (hyperventilation). She has fever, and high crp 250. Suspected as transplantation reaction or sepsis. They have not received the results from blood culture.
Patient Sequence No: 1, Text Type: D, B5
[21194082]
Additional information received by baxter on 06-july-2009 of lab in other country: "our staff noticed that is was very tight in the transportbox when the courier return to lab with the marrow bags. The box should have had a one or two extra rings. That is tru. We will do a addition in our sop for transport so we don't miss it more when we pick up marrow. On the other hand we saw in lifecells bag that the sealing who is around the bag was so narrow the edge in the upper corner. So it is a manufacturing fault. We have not report the case. Only our own incident reports in the quality assurance. " there is no product sample available, but pictures were received. Baxter medical assessment: this is a reported leak from a life cell tissue culture bag that was discovered after shipment and pooling of the bone marrow aspirate. The recipient of the bm transplant did develop a reaction possibly sepsis. However, no blood culture results are reported. In all cases of disruption of the container bag, there is the potential of contamination of the transplant and recipient infection as well as loss of engraftment or delay in engraftment with the loss of product. This puts the patient at greater risk. As such, a leak could potentially cause or contribute to an event if it were to reoccur. All attempts should be made to obtain results of blood cultures to determine if possible contamination of the transplant has occurred. The pictures will be evaluated and a follow-up will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2009-00036 |
| MDR Report Key | 1413277 |
| Report Source | 01,05 |
| Date Received | 2009-07-13 |
| Date of Report | 2009-07-13 |
| Date of Event | 2009-06-16 |
| Date Mfgr Received | 2009-06-25 |
| Device Manufacturer Date | 2008-04-15 |
| Date Added to Maude | 2009-07-20 |
| 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 | 0 |
| Manufacturer Contact | JOSHUA LEACH |
| Manufacturer Street | ONE BAXTER WAY |
| Manufacturer City | WESTLAKE VILLAGE CA 91362 |
| Manufacturer Country | US |
| Manufacturer Postal | 91362 |
| Manufacturer Phone | 8053723250 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TISSUE CULTURE FLASK |
| Product Code | KJA |
| Date Received | 2009-07-13 |
| Catalog Number | R4R2110 |
| Lot Number | H08D14062 |
| Device Expiration Date | 2013-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | MOUNTAIN HOME AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-13 |