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 2007-10-30 for PALL BDS SAMPLE SET BDS02 NA manufactured by Pall Medsep.
[707739]
It was reported that a unit of platelets was sampled and tested five days after the apheresis unit had been collected in a hospital blood bank prior to issue, and was found to have a ph of 5. 7. The unit was then submitted to the hospital laboratory for confirmatory culture testing, in which growth was observed, identified as gram-positive coccl (gpc). The platelet unit was discarded (not transfused to a patient). The platelet unit had previously been tested with the bacterial detection device, which had made a determination, based on a headspace oxygen concentration of 14. 98%, that the unit was not contaminated.
Patient Sequence No: 1, Text Type: D, B5
[7861996]
Device evaluation started, but not yet completed.
Patient Sequence No: 1, Text Type: N, H10
[8023711]
A review of the release testing of the oxygen analyzer confirmed that the instrument conformed to specifications required for release. A review of the manufacturing history for the sample pouch lot used in the testing indicated no deviation that would be likely to be related to the user's reports. No similar reports have been reported from other blood centers using this lot. Because the sample pouch involved in the event was discarded, and specimens of the grown-out bacteria were not provided to the firm for an attempted reproduction of the reported event, the conclusions stated below are based on information, including the data log retrieved from the oxygen analyzer, provided to the firm by the user. It is likely that the apheresis unit in question was contaminated. This is supported by low ph readings and the hospital laboratory's confirmatory culture test results. There is no indication during review of the data log that there was a malfunction of the oxygen analyzer. The measured oxygen level of 14. 98% that was recorded in the data log, which corresponds to a "pass" result is typical of non-contaminated samples from an apheresis unit. Based on this information, the most probable cause of the pass determination from the ebds bacterial detection system is that the level of bacteria (cfu/ml) in the apheresis unit was sufficiently low that the 4 ml sample from the platelet unit did not include viable bacteria. This phenomenon is a result of the statistical variation in sampling. This phenomenon is described in the labeling for the ebds: the hospital blood bank's policy is to screen platelets prior to issuance from transfusion. In this case, the screen excluded this platelet unit, and the platelets were not issued for transfusion. There were no clinical sequelae. Unless substantially significant information becomes available, this constitutes a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2013342-2007-00008 |
| MDR Report Key | 934939 |
| Report Source | 05,06,07 |
| Date Received | 2007-10-30 |
| Date of Report | 2007-10-05 |
| Date of Event | 2007-08-15 |
| Date Facility Aware | 2007-08-15 |
| Date Reported to Mfgr | 2007-10-05 |
| Date Mfgr Received | 2007-10-05 |
| Device Manufacturer Date | 2007-06-22 |
| Date Added to Maude | 2008-06-13 |
| 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 | PALL MEDSEP |
| Manufacturer Street | 1626 INDUSTRIAL PARK ST. |
| Manufacturer City | COVINA CA 91722431 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91722 4319 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL BDS SAMPLE SET |
| Generic Name | MZC: IMMUNOLOGY (SPECIALITY) |
| Product Code | MZC |
| Date Received | 2007-10-30 |
| Model Number | BDS02 |
| Catalog Number | NA |
| Lot Number | 0754039 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 930791 |
| Manufacturer | PALL MEDSEP |
| Manufacturer Address | 1626 INDUSTRIAL PARK ST. COVINA CA 917224319 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-30 |