MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-23 for POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 6806676 manufactured by Brea Discrete Mfg Io.
[142793852]
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).
Patient Sequence No: 1, Text Type: N, H10
[142793853]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2050012-2019-01071 |
| MDR Report Key | 8540720 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-23 |
| Date of Event | 2019-03-26 |
| Date Facility Aware | 2019-03-29 |
| Date Mfgr Received | 2019-03-29 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2019-04-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DAVID DAVIS |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal | 928218000 |
| Manufacturer Phone | 7149613796 |
| Manufacturer G1 | BREA DISCRETE MFG IO |
| Manufacturer Street | 250 S. KRAEMER BLVD |
| Manufacturer City | BREA CA 928218000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 928218000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: |
| Generic Name | RADIOASSAY, VITAMIN B12 |
| Product Code | CDD |
| Date Received | 2019-04-23 |
| Catalog Number | 6806676 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BREA DISCRETE MFG IO |
| Manufacturer Address | 250 SOUTH KRAEMER BLVD. BREA CA 928218000 US 928218000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-23 |