BULK PACK TRANSDUCER PROTECTOR
Received Nov 7, 2017 · Event occurred Nov 6, 2017
Report 8030665-2017-00946 · MDR key 7008585
Device
Generic name
Protector, Transducer, Dialysis
Manufacturer
Erika De Reynosa, S.a. De C.v.Catalog number
04-9500-2
Lot number
15SR01122
Product problems
- Fluid/Blood Leak
- Detachment of Device or Device Component
- Fluid/Blood Leak
- Detachment of Device or Device Component
Patient
71 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 500MLS. NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS GIVEN A SALINE BOLUS AND REFUSED TO GO TO THE EMERGENCY ROOM. WHEN THE PATIENT WAS STABLE SHE WENT TO THE HOSPITAL AND HAD A HEMOGLOBIN (HGB) DRAWN AND IT WAS WITHIN NORMAL LIMITS. 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 DID NOT COMPLETE HEMODIALYSIS TREATMENT. 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 500MLS. NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS GIVEN A SALINE BOLUS AND REFUSED TO GO TO THE EMERGENCY ROOM. WHEN THE PATIENT WAS STABLE SHE WENT TO THE HOSPITAL AND HAD A HEMOGLOBIN (HGB) DRAWN AND IT WAS WITHIN NORMAL LIMITS. 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 DID NOT COMPLETE HEMODIALYSIS TREATMENT. THE SAMPLE WAS DISCARDED.