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Recalls and Significant Blood Safety Violations

10/30/09:
Three whole blood units were individually identified at the collection site as overweight. Three components manufactured from those units were distributed. The Region was unaware that the three components had been distributed until the FDA investigator identified the violations during the inspection. After the FDA investigator discovered that the components had been distributed, ARC notified the consignees and learned that they had been transfused. Collection staff did not correctly manage an instrument alarm and did not take steps to control the associated suspect Red Blood Cells, (Apheresis) unit and prevent it distribution. The component was distributed. The Region failed to log the problem into the automated problem management system (APMS), investigate, or develop a corrective action plan for more than two months after the problem was initially discovered. The Region collected 75 overweight whole blood units and failed to log in the Automated Problem Management System (APMS), investigate, correct, and trend any of those problems. Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (Blood Donation Record question related to CJD was unanswered).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to failure to control suspect blood component(s) (inappropriate release of blood components that should have been discarded).

10/30/09:
Recalled 1 Cryoprecipitated AHF Product due to failure to control suspect blood component(s) (inappropriate release of blood components that should have been discarded).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered).

10/30/09:
Recalled 1 Red Blood Cells (Apheresis) Leukocytes Reduced Product due to collection (sterility may have been compromised).

10/30/09:
Recalled 1 Platelets Pheresis Leukocytes Reduced Product due to failure to control suspect blood component(s) (supervisory review did not identify that the products failed the pH requirement).

10/30/09:
Recalled 1 Platelets Pheresis Leukocytes Reduced Irradiated Product due to failure to control suspect blood component(s) (supervisory review did not identify that the products failed the pH requirement).

10/30/09:
Recalled 2 Red Blood Cells (Apheresis) Leukocytes Reduced Product due to quality control and distribution (failure to perform QC on the pheresis machine).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered).

10/30/09:
Recalled 1 Platelets Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered).

10/30/09:
Recalled 4 Red Blood Cells (Apheresis) Leukocytes Reduced Products due to quality control and distribution (failure to perform quality control testing on product).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered).

10/30/09:
Recalled 1 Cryoprecipitated AHF Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered).

10/30/09:
Recalled 3 Platelets Pheresis Leukocytes Reduced Products due to quality control and distribution (failure to perform platelet count).

The following excerpt is from page 1 of this 5-page FDA Inspection Report:

Specifically, the final quality review of adverse donor reactions,as documented on the internal form titled [REDACTED TEXT] are not always completed,are not always completed within a reasonable amount of time or are not always completed in accordance with the [REDACTED TEXT] limited directed by the internal document dated June 1, 2010 and titled [REDACTED TEXT].

Download the pdf file to read the complete inspection report.