OXYGENATOR
Report
- Report Number
- 8010762-2025-0000347
- Event Type
- Malfunction
- Date Received
- August 12, 2025
- Date of Event
- July 29, 2025
- Report Date
- August 29, 2025
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DTZ
- PMA / PMN Number
- K132829
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IT WAS REPORTED THAT DURING THE EXTRACORPOREAL CIRCULATION (ECC) TWO SEPARATE CASES HAD OCCURRED WITH THE ABNORMAL PRESSURE VALUES. IN BOTH CASES, THE POST OXYGENATOR PRESSURE (P2) WAS ABNORMALLY LOW, PARTICULARLY WITH THE HAHNENBANK LINE OPEN. ON (B)(6) 2025, AFTER CANNULATION, P2 VALUES DROPPED SIGNIFICANTLY. DESPITE REPLACING THE ENTIRE PRESSURE MEASUREMENT SYSTEM (TRANSDUCER, PROTECTOR, THREE-WAY STOPCOCK), THE ISSUE PERSISTED. HOWEVER, FLOW AND CLINICAL INDICATORS WERE NORMAL, SO ECC CONTINUED. THIS EVENT WILL BE INVESTIGATED ON COMPLAINT ONETRACK #(B)(4) (MFG REPORT NUMBER: 8010762-2025-0000346). ON (B)(6) 2025, SAME ISSUE RE-OCCURRED WITH SECOND OXYGENATOR. THIS TIME, CUSTOMER CHANGED THE HEART-LUNG MACHINE WITH A TERUMO SYSTEM AND PRESSURES NORMALIZED. THIS EVENT WILL BE INVESTIGATED IN THIS COMPLAINT. FOR BOTH CASES, THERE WERE NO FAILURES DETECTED DURING THE PRIMING BEFORE TREATMENT. SAMPLE INVESTIGATION COULD NOT BE PERFORMED SINCE THE PRODUCT WAS DISCARDED BY CUSTOMER. BASED ON THE INVESTIGATION RESULTS, NEITHER AN EXACT CAUSE OF THE REPORTED FAILURE COULD BE DETERMINED NOR A PRODUCT RELATED INFLUENCES COULD BE CONFIRMED. A MEDICAL CONSULTATION WAS PERFORMED BY GETINGE MEDICAL AFFAIRS ON (B)(6) 2025 WITH FOLLOWING CONCLUSION, INCLUDING SUMMARY OF PROVIDED PROTOCOL BY CUSTOMER: SUBCLAVIAN CANNULATION WAS PERFORMED WITH A 20 FR ARTERIAL CANNULA. AFTER CANNULATION, P2 VALUES DROPPED SIGNIFICANTLY. DESPITE THIS, FLOW AND CLINICAL INDICATORS REMAINED NORMAL, SO ECC WAS CONTINUED. THE CUSTOMER THEN CHANGED THE HEART-LUNG MACHINE TO A TERUMO SYSTEM, AFTER WHICH THE PRESSURES NORMALIZED. THE ORIGINAL HLS USED WAS A LIVANOVA S5. THE SET WAS DISPOSED OF AND THEREFORE NOT AVAILABLE FOR INVESTIGATION. AFTER SWITCHING TO THE NEW HLM WITH THE TERUMO SYSTEM, PRESSURES AND DELTA-P WERE NORMAL WHILE USING THE SAME CANNULAS. NO FAILURES WERE DETECTED DURING PRIMING BEFORE TREATMENT. NO HARM TO ANY PERSON AND NO LOSS OF BLOOD FLOW WERE REPORTED. THE EXACT CONFIGURATION OF THE EXTRACORPOREAL CIRCUIT CANNOT BE DETERMINED FROM THE COMMUNICATION, THOUGH THE CONSTRUCTION AND PARAMETER MEASUREMENT ARE ASSUMED TO BE APPROPRIATE FOR THE INSTITUTION¿S CLINICAL REQUIREMENTS. UNRECOGNIZED CHANGES IN TUBING CALIBER, STOPCOCK BORE SIZE, OR TUBING LENGTH MAY HAVE INFLUENCED THE OBSERVED EVENT. ACCORDING TO POISEUILLE¿S LAW, TUBING LENGTH HAS A DIRECT EFFECT ON DELTA P, BUT SMALL INCREASES OR DECREASES IN RADIUS OR CALIBER HAVE A MUCH GREATER EFFECT TO THE FOURTH POWER. MINOR CHANGES IN THE INTERNAL DIAMETER OF A STOPCOCK OR TUBING, COMPARED TO PREVIOUS SETS, MAY HAVE AFFECTED THE DELTA P REPORTED BY THE CUSTOMER. THE ACCESSORY PRODUCTS USED BY THE CUSTOMER ARE UNKNOWN, AND SINCE THE PRODUCT WAS DISPOSED OF INVESTIGATION COULD NOT BE PERFORMED, AND THEREFORE NO REASONABLE ROOT CAUSE COULD BE PROPOSED. BESIDES, IT APPEARS FROM THE COMPLAINT NARRATIVE AS WELL AS FROM THE PROTOCOL DOCUMENT SUBMITTED TO GETINGE FROM THE CUSTOMER THE FOLLOWING POSSIBILITIES WERE RULED OUT BY THE CUSTOMER AS POTENTIAL ROOT CAUSES: DEFECTIVE TRANSDUCER OR MONITORING HARDWARE. THE ENTIRE PRESSURE MEASUREMENT SYSTEM (INCLUDING THE TRANSDUCER) WAS REPLACED DURING THE PROCEDURE WITHOUT IMPROVEMENT, MAKING A DEFECTIVE TRANSDUCER UNLIKELY. NORMALIZATION AFTER SWITCHING TO TERUMO SYSTEM FURTHER RULES THIS OUT. RESIDUAL AIR OR COMPLIANCE IN THE PRESSURE LINE. WHILE AIR OR COMPLIANCE CAN DAMPEN PRESSURE SIGNALS, THIS WAS ADDRESSED BY REPLACING THE PRESSURE MONITORING SETUP. PERSISTING LOW P2 AFTER THESE MEASURES MAKES THIS EXPLANATION IMPROBABLE. INCORRECT ZEROING OR LEVELING. PRIMING AND ZEROING WERE CONFIRMED AS CORRECT BEFORE INITIATION OF ECC, REDUCING THE LIKELIHOOD OF SETUP ERROR. CIRCUIT OBSTRUCTION (CLOT, THROMBUS). NO DEPOSITS OR THROMBI WERE OBSERVED IN THE RINSED CIRCUIT OF ONE CASE, ACT VALUES WERE THERAPEUTIC (>400 SEC), AND FLOW REMAINED STABLE, MAKING OBSTRUCTION UNLIKELY. PATIENT-RELATED HEMODYNAMIC FACTORS. THERE WAS NO EVIDENCE OF SYSTEMIC PRESSURE INSTABILITY OR REDUCED FLOW TO SUGGEST A PATIENT-INDUCED CAUSE BUT MAY HAVE HAD AN IMPACT ON THE PRE-OXYGENATOR (P1) PRESSURE AS WELL. AS THE P1 WAS REPORTED AS WITHIN NORMAL LIMITS, THIS MAY ALSO BE RULED OUT. LAST, THE CUSTOMER MENTIONED THAT THE PRODUCT APPEARED TO PERFORM AS EXPECTED. AS SUCH, NO DIMINUTION IN PRODUCT PERFORMANCE (E.G., BLOOD FLOW, GAS EXCHANGE, ECT.) CAN BE ADVANCED IN EITHER OF THESE COMPLAINTS. THE LOT NUMBER OF THE OXYGENATOR WAS PROVIDED WITHIN THE PROVIDED PROTOCOL DOCUMENT BY CUSTOMER. BASED ON THE PROVIDED LOT NUMBER OF THE CONSUMED OXYGENATOR, THE CORRESPONDING FINISHED PRODUCTS SOLD TO THE REPORTED HOSPITAL WERE IDENTIFIED IN SAP. ONLY ONE BATCH NUMBER WAS FOUND IN THE SYSTEM: - LOT #3000410136, MATERIAL #701067951, BO-VKMO 71000 ¿ SQUADR-I HMO71000 + VHK71000. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED BO-VKMO 71000 WITH LOT# 3000410136 WAS REVIEWED ON 2025-08-14. ACCORDING TO THE DHR RESULT, THE PRODUCT BO-VKMO 71000 PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS, PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED QUADROX-I ADULT WITH LOT# 3000404116 WAS REVIEWED ON (B)(6) 2025. ACCORDING TO THE DHR RESULT, THE PRODUCT QUADROX-I ADULT PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS, PRODUCTION RELATED INFLUENCES ARE UNLIKELY. IN A TWO-YEAR TREND SEARCH (THE SHELF LIFE OF THE PRODUCT), NO DIRECT COMPLAINT RECORD RELATED TO A DECREASE OF P2 WITH THE HAHNENBANK LINE OPEN WAS FOUND. THEREFORE, THE TWO REPORTED COMPLAINTS MAY BE CONSIDERED A SINGLE CASE, AS THEY WERE BOTH RECEIVED FROM THE SAME CUSTOMER. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND PRODUCT AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING.
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
COMPLAINT # (B)(4).
IT WAS REPORTED THAT DURING THE EXTRACORPOREAL CIRCULATION (ECC) TWO SEPARATE CASES WERE OCCURRED WITH THE ABNORMAL PRESSURE VALUES. IN BOTH CASES, THE POST OXYGENATOR PRESSURE (P2) WAS ABNORMALLY LOW, PARTICULARLY WITH THE HAHNENBANK LINE OPEN. ON 2025-07-25, AFTER CANNULATION, P2 VALUES DROPPED SIGNIFICANTLY. DESPITE REPLACING THE ENTIRE PRESSURE MEASUREMENT SYSTEM (TRANSDUCER, PROTECTOR, THREE-WAY STOPCOCK), THE ISSUE PERSISTED. HOWEVER, FLOW AND CLINICAL INDICATORS WERE NORMAL, SO ECC CONTINUED. THIS EVENT WILL BE INVESTIGATED WITHIN THE COMPLAINT # (B)(4). ON 2025-07-29, SAME ISSUE RE-OCCURRED WITH SECOND OXYGENATOR. THIS TIME, CUSTOMER CHANGED THE HEART-LUNG MACHINE WITH A TERUMO SYSTEM AND PRESSURES NORMALIZED. THIS SECOND EVENT WILL BE INVESTIGATED WITHIN THIS COMPLAINT. FOR BOTH CASES, THERE WERE NO FAILURES DETECTED DURING THE PRIMING BEFORE TREATMENT. NO HARM TO ANY PERSON WAS REPORTED. SINCE THE FAILURE WAS OCCURRED DURING TREATMENT, AND ENTIRE PRESSURE MEASUREMENT SYSTEM CHANGED / HLM MACHINE CHANGE WAS REQUIRED DURING PATIENT USE, THE COMPLAINT IS REPORTABLE. COMPLAINT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1378658 | OXYGENATOR | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | MAQUET CARDIOPULMONARY GMBH | BO-VKMO 71000 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |