BULK PACK TRANSDUCER PROTECTOR
Received Nov 7, 2017 · Event occurred Nov 6, 2017
Report 8030665-2017-00947 · MDR key 7008581
Device
Generic name
Protector, Transducer, Dialysis
Manufacturer
Erika De Reynosa, S.a. De C.v.Catalog number
04-9500-2
Lot number
16AR01005
Product problems
- Fluid/Blood Leak
- Detachment of Device or Device Component
- Fluid/Blood Leak
- Detachment of Device or Device Component
Patient
61 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
A CLINIC MANAGER FROM A HEMODIALYSIS (HD) PATIENT'S FACILITY REPORTED DURING HD TREATMENT THE TRANSDUCER PROTECTOR CAME LOOSE FROM THE DIALYSIS LINES AND EXPERIENCED BLOOD LOSS DURING THE EVENT. ADDITIONAL FOLLOW-UP REVEALED THE TRANSDUCER PROTECTOR CAME LOOSE ONE HOUR AFTER TREATMENT WAS INITIATED. THE ESTIMATED BLOOD LOSS WAS 20MLS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS MONITORED AND HER VITAL SIGNS REMAINED STABLE. NO DEFECT OR DAMAGE WAS OBSERVED TO THE TRANSDUCER PROTECTOR OR ITS PACKAGING. THE PATIENT WAS ABLE TO SUCCESSFULLY COMPLETE TREATMENT ON THE SAME MACHINE. THE SAMPLE WAS DISCARDED.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.
Description of Event or Problem
A CLINIC MANAGER FROM A HEMODIALYSIS (HD) PATIENT'S FACILITY REPORTED DURING HD TREATMENT THE TRANSDUCER PROTECTOR CAME LOOSE FROM THE DIALYSIS LINES AND EXPERIENCED BLOOD LOSS DURING THE EVENT. ADDITIONAL FOLLOW-UP REVEALED THE TRANSDUCER PROTECTOR CAME LOOSE ONE HOUR AFTER TREATMENT WAS INITIATED. THE ESTIMATED BLOOD LOSS WAS 20MLS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS MONITORED AND HER VITAL SIGNS REMAINED STABLE. NO DEFECT OR DAMAGE WAS OBSERVED TO THE TRANSDUCER PROTECTOR OR ITS PACKAGING. THE PATIENT WAS ABLE TO SUCCESSFULLY COMPLETE TREATMENT ON THE SAME MACHINE. THE SAMPLE WAS DISCARDED.