J.L. SHEPHERD BLOOD IRRADIATOR 143-68A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-08-06 for J.L. SHEPHERD BLOOD IRRADIATOR 143-68A manufactured by J.l. Shepherd & Associates.

Event Text Entries

[1190167] The j. L. Shepherd blood irradiator is utilized to irradiate blood and blood products. In order to provide uniform exposure to the irradiation source and thus ensure a predictable dose, the canister containing the blood unit-s rotates during the irradiation cycle. Rotation is confirmed by a light on the device instrument panel. This single visual reference is the only indication that the canister is rotating. There is no alarm that designates failure mode and the device has no computer/software interface to record and monitor device output or flag a mechanical failure of any nature. This compels users to manually record all activity and assures that intermittent failures i. E. , initial rotation followed by one or more failures during a cycle - may not be noticed by a user who has not been able to observe the light continuously during operation. Failure to properly irradiate a blood component may have serious consequences for patients who require this type of blood product. The manufacturer should upgrade all devices to provide at least an audible alarm or computer generated message/alert to designate serious mechanical failure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5012322
• MDR Report Key: 1436254
• Date Received: 2009-08-06
• Date of Report: 2009-08-06
• Date of Event: 2009-08-06
• Date Added to Maude: 2009-08-14
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• 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: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: J.L. SHEPHERD BLOOD IRRADIATOR
• Generic Name: BLOOD IRRADIATOR
• Product Code: MOT
• Date Received: 2009-08-06
• Model Number: 143-68A
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: J.L. SHEPHERD & ASSOCIATES
• Manufacturer Address: 1010 ARROYO AVE. SAN FERNANDO CA 91340182 US 91340 1822

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2009-08-06