UNSPECIFIED BD PRIMARY ALARIS SET
Report
- Report Number
- 2243072-2020-02323
- Event Type
- Malfunction
- Date Received
- January 14, 2021
- Date of Event
- December 21, 2020
- Report Date
- July 14, 2021
- Manufacturer
- SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
- Product Code
- FPA
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING HAS BEEN UPDATED: D.3. MEDICAL DEVICE MANUFACTURER: TIJUANA, MX. D.4. MEDICAL DEVICE MATERIAL #: 24302-0004. G.1. MANUFACTURING LOCATION: TIJUANA, MX. H.6 INVESTIGATION: ONE SAMPLE OF A PRIMARY INFUSION SET, WITH A SECONDARY SET ATTACHED, WAS RECEIVED FOR QUALITY INVESTIGATION. BASED ON AN INVESTIGATION OF THE COMPONENTS ON THE INFUSION SET, IT WAS DETERMINED THAT THE SAMPLE MATERIAL NUMBER IS 24302-0004. THE CUSTOMERS COMPLAINT OF FLOW ISSUES - BACK FLOW WAS VERIFIED BY TESTING, HOWEVER, THE ISSUE WAS ONLY REPLICATED WHEN THE BLUE TUBE CLAMP WAS NOT ENGAGED CORRECTLY. VISUAL INSPECTION OF THE INFUSION SET, ALONG WITH REVIEW OF THE INFUSION SET CONSTRUCTION DRAWING, REVEALED THAT THIS INFUSION SET DID NOT HAVE A BACK CHECK VALVE ON IT. ADDITIONALLY, THERE IS A KINK BELOW THE FIRST Y-SITE SMARTSITE ON THE INFUSION SET. INITIALLY THIS WAS THOUGHT TO BE THE CAUSE OF THE BACKFLOW, HOWEVER THE KINK WAS EXAMINED FURTHER AND WAS NOT THE CAUSE OF THE BACK FLOW. UPON PRIMING THE INFUSION SET AND SETTING A SIMULATED INFUSION AT A RATE OF 125 ML/HR, THERE WERE NO INDICATIONS OF LEAKAGE AND OCCLUSION, HOWEVER, WHEN CONNECTING A SECONDARY IV LINE TO THE FIRST Y-SITE SMART SITE, BEFORE THE PUMP, BACK FLOW WAS NOTICED BACK INTO THE SECONDARY IV LINE. THE CLAMP ON THE PRIMARY LINE WAS THEN ENGAGED AND THE BACK FLOW INTO THE INFUSION BAG WAS HALTED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 24302-0004 BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THE ISSUE SEEN IN THIS COMPLAINT IS A MISUSE OF THE INFUSION SET BY THE USER. BACK FLOW COULD ONLY BE REPLICATED WITH THE SAMPLES PROVIDED WHEN THE TUBING WAS NOT USED CORRECTLY AND THE CLAMP WAS NOT UTILIZED CORRECTLY.
H.6. INVESTIGATION: ONE SAMPLE OF A PRIMARY INFUSION SET, WITH A SECONDARY SET ATTACHED, WAS RECEIVED FOR QUALITY INVESTIGATION. THE CUSTOMERS COMPLAINT OF FLOW ISSUES - BACK FLOW WAS VERIFIED BY TESTING, HOWEVER, THE ISSUE WAS ONLY REPLICATED WHEN THE BLUE TUBE CLAMP WAS NOT ENGAGED CORRECTLY. VISUAL INSPECTION OF THE INFUSION SET REVEALED THAT THIS INFUSION SET DID NOT HAVE A BACK CHECK VALVE ON IT. WE CANNOT VERIFY THE CUSTOMERS CLAIM OF A CHECK VALVE FAILURE BECAUSE THE CUSTOMER DID NOT PROVIDE A MATERIAL NUMBER, AND THEREFORE WE COULD NOT VERIFY THAT THIS INFUSION SET IS NORMALLY CONSTRUCTED WITH A CHECK VALVE. ADDITIONALLY, THERE IS A KINK BELOW THE FIRST Y-SITE SMARTSITE ON THE INFUSION SET. INITIALLY THIS WAS THOUGHT TO BE THE CAUSE OF THE BACKFLOW, HOWEVER THE KINK WAS EXAMINED FURTHER AND WAS NOT THE NOT CAUSE OF THE BACK FLOW. UPON PRIMING THE INFUSION SET AND SETTING A SIMULATED INFUSION AT A RATE OF 125 ML/HR, THERE WERE NO SIGNIFICANT INDICATIONS OF LEAKAGE AND OCCLUSION, HOWEVER, WHEN CONNECTING A SECONDARY IV LINE TO THE FIRST Y-SITE SMART SITE, BEFORE THE PUMP, BACK FLOW WAS NOTICED BACK INTO THE SECONDARY IV LINE. THE CLAMP ON THE PRIMARY LINE WAS THEN ENGAGED AND THE BACK FLOW INTO THE INFUSION BAG WAS HALTED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL OR LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE OF THE ISSUE SEEN IN THIS COMPLAINT IS A MISUSE OF THE INFUSION SET BY THE USER. BACK FLOW COULD ONLY BE REPLICATED WITH THE SAMPLES PROVIDED WHEN THE TUBING WAS NOT USED CORRECTLY AND THE CLAMP WAS NOT UTILIZED CORRECTLY.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 1/11/2021. H.6. INVESTIGATION: ONE SAMPLE WAS RECEIVED FOR QUALITY INVESTIGATION. THE CUSTOMERS COMPLAINT OF FLOW ISSUES - BACK FLOW WAS VERIFIED BY TESTING. VISUAL INSPECTION OF THE INFUSION SET REVEALED THAT THERE IS A KINK BELOW THE FIRST Y-SITE SMARTSITE ON THE INFUSION SET. UPON PRIMING AND SETTING THE INFUSION SET AT A RATE OF 125 ML/HR, THERE WERE NO SIGNIFICANT INDICATIONS OF LEAKAGE AND OCCLUSION, HOWEVER, WHEN CONNECTING A SECONDARY IV LINE TO THE FIRST Y-SITE SMART SIDE, BEFORE THE PUMP, BACK FLOW WAS NOTICED BACK INTO THE SECONDARY IV LINE. THE KINK IN THE TUBING ON THE Y-SITE SMARTSITE IS SIGNIFICANT ENOUGH TO CAUSE THE BACK FLOW OF FLUID INTO THE IV BACK. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL OR LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE ROOT CAUSE ANALYSIS INDICATES THAT THE KINK IS CAUSING THE BACK FLOW ISSUES. THE KINKING IN THE TUBE IS SEEN WHEN THE INFUSION SET IS COILED AND POUCHED PRIOR TO THE SOLVENT FULLY DRYING DURING THE ASSEMBLY PROCESS.
IT WAS REPORTED THAT UNSPECIFIED BD¿ PRIMARY ALARIS SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT A SECONDARY IV MEDICATION HUNG AND LESS THAN 5 MINUTES LATER NURSE NOTICED IV MED WAS EMPTY. THE PRIMARY BAG WAS MORE FULL THAN BEFORE THE SECONDARY IV MEDICATION WAS STARTED.
IT WAS REPORTED THAT UNSPECIFIED BD¿ PRIMARY ALARIS SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN, BATCH NO: UNKNOWN. IT WAS REPORTED THAT A SECONDARY IV MEDICATION HUNG AND LESS THAN 5 MINUTES LATER NURSE NOTICED IV MED WAS EMPTY. THE PRIMARY BAG WAS MORE FULL THAN BEFORE THE SECONDARY IV MEDICATION WAS STARTED.
IT WAS REPORTED THAT UNSPECIFIED BD¿ PRIMARY ALARIS SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN. BATCH NO: UNKNOWN. IT WAS REPORTED THAT A SECONDARY IV MEDICATION HUNG AND LESS THAN 5 MINUTES LATER NURSE NOTICED IV MED WAS EMPTY. THE PRIMARY BAG WAS MORE FULL THAN BEFORE THE SECONDARY IV MEDICATION WAS STARTED.
UNKNOWN MANUFACTURER: (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).
IT WAS REPORTED THAT UNSPECIFIED BD¿ PRIMARY ALARIS SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN. IT WAS REPORTED THAT A SECONDARY IV MEDICATION HUNG AND LESS THAN 5 MINUTES LATER NURSE NOTICED IV MED WAS EMPTY. THE PRIMARY BAG WAS MORE FULL THAN BEFORE THE SECONDARY IV MEDICATION WAS STARTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71348 | UNSPECIFIED BD PRIMARY ALARIS SET | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS, S.A. DE C.V. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |