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..
[940457]
It was reported that a hospital end-user cultured a two platelet units that had been split at the collection site from an apheresis-collected platelet unit in 2008. The apheresis unit had been tested for bacterial contamination using the device, prior to the splitting. The culture of one of the split units grew coagulase-negative staphylococcus; the culture of the other spilt unit was negative. The first split unit was transfused at 4 days post-collection. The culture had not been completed at that time. The patient receiving the transfusion died; however, the death was unrelated to the transfusion. The second split unit was transfused at day 5 post-collection without sequelae.
Patient Sequence No: 1, Text Type: D, B5
[8226941]
Recapitulation of user report: the apheresis platelet unit collected in 2008 (day 0) at the reporter's facility was sampled after 25 hr room temperature hold, and after 18 hr incubation at 35? C, the sample was tested using ebds for % oxygen and measured at 16. 79% (pass) twelve days later. The apheresis unit was split into two platelet products and both were sent to a hospital transfusion facility "a". It is the policy of transfusion facility a to culture platelet units at the time of issue for transfusion. Split unit was transfused on day five with no adverse patient reaction reported; the culture of an aliquot of this unit was negative. An aliquot of split unit was sent for culture on day 2 and the split unit was shipped to transfusion facility "b". This split unit was not transfused at facility b and was returned to facility a on day 3, when a 2nd aliquot was sent for culture prior to issuance of the split unit for transfusion. Approximately two hours later, on day 4, the split unit was transfused and a transfusion reaction consisting of a 1 degree c increase in temperature was observed. A 3rd aliquot was sent for culture and gram stain. Of the three cultures: the first was negative, but the 2nd and 3rd cultures were positive for coagulase-negative staphylococcus, which was subsequently identified as s. Warneri. 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 from the oxygen analyzer revealed that on the days, unit that was tested 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 (unit) 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 and produced (0. 5 x 10e7 cfu) concentration. 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. 75 (? 0. 07) %. This study demonstrates the bacteria isolate can be detected by ebds. Discussion: the grow-out of the 2nd and 3rd aliquots of split product may signify that a low cfu level in the split product did not reach a cfu level detectable by culture at day 2 room temperature storage, but attained a detectable cfu level by culture at day 4. Alternatively, it is possible the later positive cultures were an artifact of the sampling process for this split unit on day 2. The appearance of positive cultures on day 4 is consistent with hospital as inadvertent inoculation of s. Wagneri into the split unit from the environment on day 2. Two days of room temperature storage of the split unit would then potentially allow growth of the inadvertent contaminant, and produce the positive cultures seen from the two aliquots taken on day 4. S. Wagneri has been described as a skin commensal. Summary: in conclusion, there appears to be no evidence that the oxygen analyzer or device disposables malfunctioned. For unit, the existence of both positive and negative cultures from the two different splits, and both negative and positive cultures from one split, make a clear-cut evaluation difficult. If there was not a correct determination of "negative" by the ebds (the determination may indeed be correct) then the growth and metabolic characteristics of s. Wagneri may have produced these varying results. Alternatively, the presence of contamination found in the split product that was cultured may have been introduced inadvertently during an earlier sampling from that same split unit. Also unclear is the relationship of the reported one degree c temperature increase transfusion reaction in the patient to the possible contamination in the split unit. The ebds sample pouch labeling, excerpted below, describes outcomes that are consistent with the circumstances in this report. "precautions and limitations of procedure 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. 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. Unless substantially significant information becomes available, this constitutes a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9617787-2008-00019 |
| MDR Report Key | 1138343 |
| 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 | 2009-06-30 |
| 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 0854009 |
| Operator | HEALTH PROFESSIONAL |
| 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 |