MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-08-29 for PALL BDS SAMPLE SET BDS02 manufactured by Ensatec, S.a. De C.v..
[932411]
It was reported that an end user facility cultured a platelet unit that had been split from a apheresis platelet unit collected in 2008, that had tested negative for bacterial contamination using the device following donation at the collection facility. The split unit was transfused at 5 days post-collection with no transfusion reaction reported. Subsequently, the end user? S culture of the split platelet unit grew coagulase negative staphylococcus. The collection facility followed-up with the (different) end user facility that received the other half of the split unit. That split platelet had been transfused at day 4 post-collection with no transfusion reaction reported. This end-user facility does not have a policy of culturing platelets pre-transfusion.
Patient Sequence No: 1, Text Type: D, B5
[8215022]
An apheresis unit was collected in 2008, (day 0), at the reporting blood center and was sampled after 25 hr room temperature hold. After 18 hr incubation at 35? C, the sample was tested using the bacterial test system device for % oxygen, which was measured at 17. 15% (pass) two days later. The apheresis unit was split into two platelet products (12710 and 12750) at the blood center. The split products were sent to two different transfusion facilities. The split unit that was sent to hospital a on day 3 was issued for transfusion on day 5 and an aliquot was sent for culture. When the split unit was transfused, no transfusion reaction was reported. Subsequently ffp was transfused, and a transfusion reaction identified as trali occurred. The recipient expired four hours later. The aliquot of split product was tested by a direct smear as 3+ gram-positive clusters of cocci in cluster. Culture of the aliquot grew out and was then identified as s. Epidermidis. At another hospital, hospital b, split unit was not cultured, and no adverse event report was received related to its transfusion. The firm's investigation consisted of the following: review of the datalog from the oxygen analyzer from the date the unit was tested: review of the data logs of all testing by the oxygen analyzer revealed that for the day when the sample from apheresis unit id all the baseline and test values were typical of those expected for a true negative determination. Review of the manufacturing record of the sampling pouch component of the device. Review of the manufacturing records of the sampling pouches for ln 0854012 (unit id) disclosed no deviation from sops or release testing requirements that could have caused or contributed to the user's experience. Grow-out and evaluation of the isolate from the culture grown out at facility a's microbiology lab. : grow-out and evaluation of the isolate from the culture at facility a is described below. Study design: low levels of the bacteria from the isolate (1-15 cfu/ml) were inoculated into platelet concentrates, and were sampled at day-0 for growth levels (cfu/ml). Ebds pouches were filled at time-0 and incubated at 35? C agitated for 24 hours. Results/discussion: this study evaluated bacteria isolate that was received by the firm from facility a. The bacteria isolate was grown overnight in tsb produced 4. 5 x 10e7 cfu/ml concentration. The bacteria isolate. Which was identified as coagulase-negative staphylococcus, can be detected by ebds. The results from ebds testing of the bacteria isolate were: based on a pass/fail threshold of 9. 4% oxygen, the platelet unit inoculated with the isolate failed with an overall average oxygen reading of 0. 63 (sd 0. 07) %. This study demonstrates the bacteria isolate can be detected by ebds. Discussion: with regard to the positive culture of split platelet product 12750, it is possible that the bacterial contamination was missed by the bacterial detection device testing of apheresis unit because the sample volume did not contain a viable bacterium due to the statistical distribution of bacteria in a low cfu level of contamination. Clinically, the temporal relationship of the ffp transfusion and the symptoms of trali and the lack of symptoms following the prior platelet transfusion of split platelet product 12750 indicate that the death of the recipient was unlikely to be related to the split platelet product (and the unclear state of its bacterial contamination or freedom therefrom). The ebds sample pouch labeling, excerpted below, describes outcomes that are consistent with the certain of the circumstances in this report. "precautions and limitations of procedure 1. Users need to be aware that certain bacteria grow very slowly, and if the initial contamination level with such bacteria is very low, the aliquot taken for ebds testing may not contain any bacteria. In these cases the bacteria will not be detected, and a negative result ("pass") ") will be indicated. Longer hold times of the platelet product prior to sampling are likely to enhance the ability to detect these slow growing organisms. 2. Bacteria that do not grow to sufficient levels in the platelet unit or in the sample pouch, or that do not utilize sufficient oxygen to be determined to be positive will not be detected. " in addition, the labeling reports on ebds pre-market bench test results for platelet units inoculated with staphylococcus epidermidis, in which very low cfu/ml contamination was detectable in ebds tests of some platelet units, but not in all platelet units. Summary: in conclusion, there appears to be no evidence that the oxygen analyzer or device disposables malfunctioned. Unless substantially significant information becomes available, this constitutes a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617787-2008-00020 |
| MDR Report Key | 1138383 |
| Report Source | 05,06,07 |
| Date Received | 2008-08-29 |
| Date of Report | 2008-08-13 |
| Date of Event | 2008-07-25 |
| Report Date | 2008-08-13 |
| Date Reported to Mfgr | 2008-08-13 |
| Date Mfgr Received | 2008-08-13 |
| Date Added to Maude | 2009-05-07 |
| 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 | DR. LEONARD BERMAN |
| Manufacturer Street | 25 HARBOR PARK DR |
| Manufacturer City | PORT WASHINGTON NY 11050 |
| Manufacturer Country | US |
| Manufacturer Postal | 11050 |
| Manufacturer Phone | 5168019183 |
| Manufacturer G1 | ENSATEC, S.A. DE C.V. |
| Manufacturer Street | FRACCIONAMIENTO EL FLORIDO CALLE COLINAS #11730 |
| Manufacturer City | TIJUANA, B.C.,, 22680 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22680 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL BDS SAMPLE SET |
| Generic Name | BACTERIA DETECTION SYSTEM |
| Product Code | MZC |
| Date Received | 2008-08-29 |
| Model Number | BDS02 |
| ID Number | POUCH LOT #0854012 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENSATEC, S.A. DE C.V. |
| Manufacturer Address | FRACCIONAMIENTO EL FLORIDO CALLE COLINAS #11730 TIJUANA, B.C.,, 22680 MX 22680 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-08-29 |