Description of Event or Problem · 0
THE FOLLOWING HAS BEEN REPORTED: BD 10ML PREFILLED POSI- FLUSH SYRINGE USE TO MIX DRUGS FOR INFUSION VIA SECONDARY PORT RN EXPERIENCED UPSTREAM OCCLUSION ALARM THAT WE WERE NOT ABLE TO RESOLVE. TRIED TRANSFERRING MEDICATION VIA BLUNT TIP TO BD 10ML STANDARD SYRINGE AND STILL COULD NOT RESOLVE THE ISSUE. SWITCHED TO A 30ML SYRINGE AND WAS ABLE TO COMPLETE THE INFUSION. LATER, SAME SET, HOWEVER, MIXED DEXAMETHASONE AND NS IN A 30ML SYRINGE TO START AND ENCOUNTERED THE SAME ISSUE. WERE EVENTUALLY ABLE TO GET LARGER SYRINGE TO INFUSION. FROM NURSE: REPEATED UPSTREAM OCCLUSION ALARMS AT LEAST 10X FOR A 15 MIN AMPICILLIN INFUSION. NURSE HAD TO CLEAR ALARM MULTIPLE TIMES AND SHE WOULD PUT PRESSURE ON TOP OF SYRINGE TO GET IT TO INFUSE. SET-0032-25 LOT 3003876 CONTAINS DIAPHRAGM LOT H3M000000010831 WHICH CORRESPONDS TO THE SAINT GOBAIN DIAPHRAGM LOT 28448387, MANUFACTURED BETWEEN 02/09/22 TO 02/15/22 USING 8-CAVITY TOOLING. SAN LUIS VALLEY MAILED BD 10 ML PRE-FILLED SYRINGES (REF (B)(4) ) AND BD 10 ML STANDARD SYRINGES (REF (B)(4) ) WHICH WERE THE SAME SYRINGE TYPES FROM THE COMPLAINT. THE SPECIFIC LVP PUMP AND ADMINISTRATION SET LOT WAS NOT AVAILABLE FOR THE INITIAL INVESTIGATION (A SIMILAR ADMIN SET LOT 3004043 USING 8-CAVITY DIAPHRAGM TOOLING WAS USED INSTEAD AND ADMIN SET LOT 3003303 USING 2-CAVITY DIAPHRAGM TOOLING WAS ALSO USED FOR COMPARISON). THE INVESTIGATION SHOWED THAT THE UPSTREAM OCCLUSION ALARMS CAUSED BY THE STANDARD SYRINGES (REF (B)(4) ) APPEARED TO BE ADMINISTRATION SET SPECIFIC (ONLY OCCURRING IN SOME OF THE 8-CAVITY DIAPHRAGM TOOLING MANUFACTURED SETS). THERE WAS VARIABILITY IN THE TESTING AND NOT ALL 8-CAVITY TOOLING ADMINISTRATION SETS (LOT 3004043) / SYRINGE COMBINATIONS TRIGGER OCCLUSION ALARMS. THERE WERE NO UPSTREAM OCCLUSION ALARMS WITH THE 2-CAVITY DIAPHRAGM TOOLING ADMINISTRATION SETS (LOT 3003303) DURING THIS STUDY. ADDITIONALLY, THE INVESTIGATION SHOWED THAT BOTH THE 2-CAVITY AND THE 8-CAVITY DIAPHRAGM ADMINISTRATION SETS COULD NOT INFUSE THE BD 10 ML PRE-FILLED SYRINGES (REF (B)(4) ) WITHOUT UPSTREAM OCCLUSION ALARMS. THIS WAS CONSISTENT ACROSS MULTIPLE ADMINISTRATION SET SAMPLES AND WAS REPEATABLE. THE PRE-FILLED SYRINGES HAD NOT BEEN TESTED AND ARE NOT CLAIMED TO BE COMPATIBLE WITH THE SYSTEM. REPORTING DUE TO REFERENCED ISSUE. NO ADVERSE EFFECTS WERE REPORTED. FRESENIUS KABI HAS PERFORMED A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THIS FAILURE MODE AND HAS DECIDED TO SUBMIT AN MDR SUBMISSION AS A CONSERVATIVE MEASURE.