MAUDE Adverse Event Report: BREA DISCRETE MFG IO POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL:; RADIOASSAY, VITAMIN B12

Catalog Number 6806676

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Abrasion (1689)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

No patient involvement.Customer was injured while performing routine troubleshooting.Customer received a precautionary tetanus shot, with no further medical attention required.Based on the information provided by the customer, it determines that the customer failed to follow ifu instruction for error recovery and troubleshooting the decapper module.Per power processor decapper and recapper modules instruction for use (ifu), pn-a97252ac, chapter 3, error recovery procedures, page 3-1, a caution statement states that, ¿even when the decapper module is in pause mode, the air system is still active and applying a constant air pressure to the cap removal air cylinders.This may cause unexpected movement of the cap removal air cylinders when resolving jammed object errors at the decapper module.Use caution when resolving jammed object errors at the decapper module.¿ the failure mode was confirmed to be customer use error.Beckman coulter internal identifier is case-(b)(4).

Event Description

A customer reported an adverse event with relation to a power processor track assembly, serial number: (b)(4).The customer reported a technician performing maintenance on the decapper, and that the decapper moved after a technician freed a stuck puck.The technician during maintenance punctured their glove and the skin of the ring finger on the left hand.The injured person went to the emergency department and received a tetanus shot.The injured person did not receive further treatment for the injury.The injured person was not put on medical leave due to the injury.

• Brand Name: POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL:
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BREA DISCRETE MFG IO; 250 south kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BREA DISCRETE MFG IO; 250 s. kraemer blvd; brea CA 92821 8000
• Manufacturer Contact: david davis ; 250 s. kraemer blvd; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 8540720
• MDR Text Key: 142793852
• Report Number: 2050012-2019-01071
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590591922
• UDI-Public: (01)15099590591922(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6806676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/29/2019
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other