DHF 06 HEMOCONCENTRATOR
Report
- Report Number
- 9680841-2025-900009
- Event Type
- Malfunction
- Date Received
- May 22, 2025
- Date of Event
- April 21, 2025
- Report Date
- June 27, 2025
- Manufacturer
- SORIN GROUP ITALY
- Product Code
- KDI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ACCORDING TO FOLLOW UP, THE HEMATIC LOSS FROM THE EFFLUENT LINE OF THE HEMOCONCENTRATOR WAS NOTICED ONLY DURING USE OF THE HEMOCONCENTRATOR (MAJORITY OF THE CASE). HOWEVER THIS INFORMATION NEEDS TO BE CONFIRMED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
A.1.-A.5. NO PATIENT INFORMATION HAS BEEN PROVIDED. D.4. THE DHF 06 HEMOCONCENTRATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA (CATALOGUE NUMBER 020119801, LOT 2417900005). THE EXPIRY DATE REFERS TO THE STERILE CONVENIENCE PACK. THE UNIQUE IDENTIFIER (UDI) NUMBER IS (B)(4). G.5. THE INVOLVED DHF 06 HEMOCONCENTRATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE HEMOCONCENTRATOR (CATALOG NUMBER 05327) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K021732). H.4. THE DHF 06 HEMOCONCENTRATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE MANUFACTURING DATE REFERS TO THE STERILE CONVENIENCE PACK. H.11. LIVANOVA MANUFACTURES THE DHF 06 HEMOCONCENTRATOR. THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER LIVANOVA LEARNED THE FOLLOWING ADDITIONAL INFORMATION: - STANDARD PROCEDURE OF BUILDING AND PRIMING WAS ADOPTED BY THE CUSTOMER. THE BYPASS CIRCUIT WAS FLUID PRIMED INCLUDING THE HEMOCONCENTRATOR THROUGH THE EFFLUENT LINE AND CIRCULATED UNTIL BLOOD WAS AVAILABLE (MORE THAN 20MINUTES). AFTER ADDING THE RED BLOOD CELLS (PRBCS) AND FROZEN PLASMA (FFP) UNITS TO THE RESERVOIR, THE HEMOCONCENTRATOR EFFLUENT LINE WAS OPENED TO PRE-BYPASS ULTRAFILTRATION (PBUF) THE CIRCUIT. A PLUME OF DARK RED WAS SEEN TRAVELING DOWN THE EFFLUENT LINE TO THE CANISTER. - REGARDING PRE-BYPASS ULTRAFILTRATION PHASE (PBUF): PRIOR TO THE CONDUCT OF BYPASS, ED BLOOD CELLS (PRBCS) CAN BE WASHED IN THE HEART-LUNG MACHINE (HLM) CIRCUIT UTILIZING A HEMOCONCENTRATOR. PBUF IS A PROCESS OF ADDING BLOOD TO A CLEAR PRIMED CIRCUIT AND UTILIZING THE DILUTION AND HEMOCONCENTRATOR TO REMOVE ELECTROLYTES, THUS WASHING THE BLOOD AND BRINGING THE PRIME VOLUME DOWN TO AN APPROPRIATE SIZE/HCT (HEMATOCRIT). EVERYTHING WAS DONE AS PER NORMAL ON THE DAY IN QUESTION. - THE BLOODY EFFLUENT (HEMOLYSIS) WAS NOTICED DURING PBUF AND TRAVELED TO THE CANNISTER ATTACHED. THE BLOOD CIRCULATING IN THE BYPASS CIRCUIT MAINTAINED ITS NORMAL RED COLOR. - THE PATIENT BEGAN HAVING RED URINE DURING THE BYPASS CASE. THE PATIENT DID NOT SUFFER KIDNEY RELATED ISSUES AND WAS GIVEN LASIX (DIURETIC) AS A PREVENTATIVE. THE RED URINE WAS RESOLVED BY THE NEXT MORNING. NO TRANSFUSION WAS REQUIRED. - THE PATIENT WAS SYMPTOM FREE BEYOND THEIR NEED FOR SURGERY. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
SEE INITIAL REPORT.
LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT HEMOLYSIS IN THE PATIENT WAS OBSERVED WHILE USING A HEMOCONCENTRATOR. THE ISSUE OCCURRED AFTER PRE-BYPASS ULTRAFILTRATION (PBUF) PHASE AND IT WAS ALSO NOTICED BY THE PERFUSIONIST THAT THE LIQUID IN THE EFFLUENT TURNED DARK REDDISH. PATIENT STILL PASSING HEMOLYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2366933 | DHF 06 HEMOCONCENTRATOR | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM | KDI | SORIN GROUP ITALY | 2401000055 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |