CUSTOM COMBI SET
Report
- Report Number
- 8030665-2017-01069
- Event Type
- Malfunction
- Date Received
- December 5, 2017
- Date of Event
- November 21, 2017
- Report Date
- February 14, 2018
- Manufacturer
- ERIKA DE REYNOSA, S.A. DE C.V.
- Product Code
- FJK
- UDI-DI
- 00840861100293
- PMA / PMN Number
- K962081
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
COMMON DEVICE NAME: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE. FDA PRODUCT CODE: FJK - SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
PLANT INVESTIGATION: ONE SAMPLE WAS RECEIVED FROM THE CUSTOMER WITHOUT ORIGINAL PACKAGE OR IDENTIFIED. DURING THE EVALUATION OF THE ACTUAL SAMPLE THE ALLEGED FAILURE WAS NOT CONFIRMED IN THE STATED COMPLAINT. THE VISUAL INSPECTION AND FUNCTIONAL TEST PASSED. DURING THE PERIOD TESTED NO AIR BUBBLES INSIDE THE SYSTEM, NO LEAKS AND NO LEVEL VARIATION OF VENOUS AND ARTERIAL CHAMBER OR ANY ALARM WERE NOTED. THE SAMPLE TESTED WORKED AS INTENDED WITHOUT ANY ABNORMALITIES DURING THE TESTED PERIOD. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WAS NO INDICATION OF PRODUCT NON-ACCEPTANCE OR DEVIATION DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE REVIEW INCLUDED A CHECK OF NON-CONFORMANCES, REWORK, LABELING, PROCESS CONTROLS, AND ANY OTHER OCCURRENCE IN PRODUCTION POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE LOT PASSED ALL RELEASE CRITERIA.
CORRECTED EXPIRATION DATE: 2020-08-31 CORRECTED OCCUPATION: HEALTH CARE PROFESSIONAL PLANT INVESTIGATION: COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVALUATION TO CONFIRM THE ALLEGED PRODUCT MALFUNCTION. A PRODUCTION RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WAS NO INDICATION OF PRODUCT NON-ACCEPTANCE OR DEVIATION DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE REVIEW INCLUDED A CHECK OF NON-CONFORMANCES, REWORK, LABELING, PROCESS CONTROLS, AND ANY OTHER OCCURRENCE IN PRODUCTION POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE LOT PASSED ALL RELEASE CRITERIA.
A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
A HEMODIALYSIS (HD) PATIENT'S CLINIC BIOMEDICAL ENGINEER (BIOMED TECH) REPORTED DURING HD TREATMENT THE TECHNICIAN NOTICED AIR IN BLOOD LINE APPROXIMATELY ONE MINUTE INTO TREATMENT. NO ALARM WAS NOTED. THE AIR WAS NOTED TO HAVE PASSED THE OCCLUSION CLAMP AROUND THE NEEDLE AREA. NO EXTERNAL LEAKS WERE NOTED. THE PATIENT WAS REMOVED FROM MACHINE AND BLOOD WAS NOT RETURNED TO PATIENT. THE PATIENT'S BLOOD LOSS WAS 300ML. THE HD PATIENT WAS UNABLE TO COMPLETE HD TREATMENT, WAS SENT TO THE EMERGENCY ROOM, EVALUATED AND RELEASED. THE PATIENT RETURNED TO THE CLINIC THE FOLLOWING DAY PER DOCTOR'S ORDER AND COMPLETED HD TREATMENT THE FOLLOWING DAY. THE ON-CALL PHYSICIAN REQUESTED THE MACHINE TO HAVE AIR DETECTOR RECALIBRATED AND AN OCCLUSION TEST WAS PERFORMED AND COMPLETED. THE SAMPLE WAS REPORTED TO HAVE BEEN AVAILABLE TO BE RETURNED FOR EVALUATION.
A HEMODIALYSIS (HD) PATIENT'S CLINIC BIOMEDICAL ENGINEER (BIOMED TECH) REPORTED DURING HD TREATMENT THE TECHNICIAN NOTICED AIR IN BLOOD LINE APPROXIMATELY ONE MINUTE INTO TREATMENT. NO ALARM WAS NOTED. THE AIR WAS NOTED TO HAVE PASSED THE OCCLUSION CLAMP AROUND THE NEEDLE AREA. NO EXTERNAL LEAKS WERE NOTED. THE PATIENT WAS REMOVED FROM MACHINE AND BLOOD WAS NOT RETURNED TO PATIENT. THE PATIENT'S BLOOD LOSS WAS 300ML. THE HD PATIENT WAS UNABLE TO COMPLETE HD TREATMENT, WAS SENT TO THE EMERGENCY ROOM, EVALUATED AND RELEASED. THE PATIENT RETURNED TO THE CLINIC THE FOLLOWING DAY PER DOCTOR'S ORDER AND COMPLETED HD TREATMENT THE FOLLOWING DAY. THE ON-CALL PHYSICIAN REQUESTED THE MACHINE TO HAVE AIR DETECTOR RECALIBRATED AND AN OCCLUSION TEST WAS PERFORMED AND COMPLETED. THE SAMPLE WAS REPORTED TO HAVE BEEN AVAILABLE TO BE RETURNED FOR EVALUATION.
A HEMODIALYSIS (HD) PATIENT'S CLINIC BIOMEDICAL ENGINEER (BIOMED TECH) REPORTED DURING HD TREATMENT THE TECHNICIAN NOTICED AIR IN BLOOD LINE APPROXIMATELY ONE MINUTE INTO TREATMENT. NO ALARM WAS NOTED. THE AIR WAS NOTED TO HAVE PASSED THE OCCLUSION CLAMP AROUND THE NEEDLE AREA. NO EXTERNAL LEAKS WERE NOTED. THE PATIENT WAS REMOVED FROM MACHINE AND BLOOD WAS NOT RETURNED TO PATIENT. THE PATIENT'S BLOOD LOSS WAS 300ML. THE HD PATIENT WAS UNABLE TO COMPLETE HD TREATMENT, WAS SENT TO THE EMERGENCY ROOM, EVALUATED AND RELEASED. THE PATIENT RETURNED TO THE CLINIC THE FOLLOWING DAY PER DOCTOR'S ORDER AND COMPLETED HD TREATMENT THE FOLLOWING DAY. THE ON-CALL PHYSICIAN REQUESTED THE MACHINE TO HAVE AIR DETECTOR RECALIBRATED AND AN OCCLUSION TEST WAS PERFORMED AND COMPLETED. THE SAMPLE WAS REPORTED TO HAVE BEEN AVAILABLE TO BE RETURNED FOR EVALUATION.
A HEMODIALYSIS (HD) PATIENT'S CLINIC BIOMEDICAL ENGINEER (BIOMED TECH) REPORTED DURING HD TREATMENT THE TECHNICIAN NOTICED AIR IN BLOOD LINE APPROXIMATELY ONE MINUTE INTO TREATMENT. NO ALARM WAS NOTED. THE AIR WAS NOTED TO HAVE PASSED THE OCCLUSION CLAMP AROUND THE NEEDLE AREA. NO EXTERNAL LEAKS WERE NOTED. THE PATIENT WAS REMOVED FROM MACHINE AND BLOOD WAS NOT RETURNED TO PATIENT. THE PATIENT'S BLOOD LOSS WAS 300 ML. THE HD PATIENT WAS UNABLE TO COMPLETE HD TREATMENT, WAS SENT TO THE EMERGENCY ROOM, EVALUATED AND RELEASED. THE PATIENT RETURNED TO THE CLINIC THE FOLLOWING DAY PER DOCTOR'S ORDER AND COMPLETED HD TREATMENT THE FOLLOWING DAY. THE ON-CALL PHYSICIAN REQUESTED THE MACHINE TO HAVE AIR DETECTOR RECALIBRATED AND AN OCCLUSION TEST WAS PERFORMED AND COMPLETED. THE SAMPLE WAS REPORTED TO HAVE BEEN AVAILABLE TO BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 863867 | CUSTOM COMBI SET | SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | FJK | ERIKA DE REYNOSA, S.A. DE C.V. | 17KR01196 | 00840861100293 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR |