Penumbra System PMX220Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 00814548012698), received between Sep 18, 2015 and Nov 24, 2021 — classified as 102 malfunctions.

The most frequently reported specific device problem is “No Pressure” (27 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2021Misconnection; Device Contamination with Body Fluid; Misconnection; Device Contamination with Body Fluid

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE HOSPITAL STAFF INADVERTENTLY CONNECTED THE ASPIRATION TUBING DIRECTLY INTO THE PUMP MAX INSTEAD OF THE CANISTER, AND CONSEQUENTLY BLOOD WAS ASPIRATED INTO THE PUMP MAX. THE PROCEDURE WAS COMPLETED USING A NEW PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12870493 ↗
• MalfunctionOct 6, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX) AND A PENUMBRA SYSTEM MAX ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, AFTER CONNECTING THE TUBING TO THE PUMP MAX, THE PHYSICIAN NOTICED THAT THERE WAS NO SUCTION BEING GENERATED FROM THE PUMP MAX. THE REGULATOR KNOB WAS THEN ADJUSTED REPEATEDLY BUT THE ISSUE WAS NOT RESOLVED. THEREFORE, THE PUMP MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH A SYRINGE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583524 ↗
• MalfunctionMar 31, 2021Suction Failure; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX) AND A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ACE60 INTO THE TARGET VESSEL AND STARTED ASPIRATION WITH THE PUMP MAX USING ADAPT TECHNIQUE. HOWEVER, THE PHYSICIAN WAS UNABLE TO ASPIRATE THE THROMBUS. SUBSEQUENTLY, IT WAS NOTED THAT THE PUMP MAX ONLY GENERATED ASPIRATION PRESSURE BETWEEN -20 INHG TO -25 INHG REGARDLESS OF ADJUSTING THE KNOB TO THE MAXIMUM SETTING. TO TROUBLESHOOT, THE ASPIRATION TUBING AND PENUMBRA CANISTER WERE CHECKED BUT NO LEAKAGE WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING THE CURRENT NEGATIVE PRESSURE THE PUMP MAX WAS GENERATING, A SYRINGE, THE SAME ACE60 AND A NON-PENUMBRA STENT RETRIEVER THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. IT WAS ALSO REPORTED THAT AFTER THE PROCEDURE, IT WAS NOTED THAT THE NEGATIVE PRESSURE OF THE PUMP MAX WAS -25 INHG WITHOUT THE CANISTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595647 ↗
• MalfunctionMar 29, 2021Power Problem; Power Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX) AND AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED A PASS USING THE CAT6 AND PUMP MAX. NEXT, THE PHYSICIAN REMOVED THE CAT6 AND THE PUMP MAX WAS TURNED OFF. AFTERWARDS, THE PHYSICIAN ADVANCED THE CAT6 FOR ANOTHER PASS AND TURNED ON THE PUMP MAX. HOWEVER, THE PUMP MAX WOULD NOT TURN ON. SUBSEQUENTLY, THE PUMP MAX TURNED ON AFTER SEVERAL ATTEMPTS WERE MADE. THE PROCEDURE WAS COMPLETED USING THE SAME PUMP MAX AND THE SAME CAT6. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586515 ↗
• MalfunctionJan 23, 2021Power Problem; Power Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE HOSPITAL STAFF NOTICED THAT FOR THE PUMP MAX TO STAY POWERED ON, THE ON/OFF BUTTON HAD TO BE ALWAYS PRESSED DOWN. THE PROCEDURE WAS COMPLETED USING THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11220001 ↗
• MalfunctionOct 5, 2020Decrease in Suction; Device Emits Odor; Decrease in Suction; Device Emits Odor

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX) AND PUMP MAX CANISTER (CANISTER). IT WAS NOTED THAT THE PROCEDURE WAS SEVERAL HOURS LONG UNDER GENERAL ANESTHESIA. DURING THE PROCEDURE, SEVERAL HOURS IN AND NEARING THE END OF THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE TOP OF THE CANISTER SAGGED UNDER ASPIRATION AND THAT THERE WAS A DECREASE IN ASPIRATION. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO ASPIRATE SOME THROMBUS BUT NOT ALL OF IT. THE PUMP MAX STOPPED WORKING AND A BURNING SMELL WAS NOTED. IT WAS ALSO REPORTED THAT THE PUMP MAX WAS TURNED ON AND OFF SEVERAL TIMES DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CANISTER AND THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THIS PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10631540 ↗
• MalfunctionJun 26, 2020Pumping Stopped; Suction Failure; Pumping Stopped; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE PUMP MAX STOPPED ASPIRATING; THEREFORE, THE PUMP MAX WAS DISCONNECTED. THE PROCEDURE WAS COMPLETED USING ANOTHER PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10200843 ↗
• MalfunctionJun 11, 2020Misconnection; Device Contamination with Body Fluid; Device Handling Problem; Misconnection; Device Contamination with Body Fluid; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA)USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, A HOSPITAL STAFF ACCIDENTALLY CONNECTED THE ASPIRATION TUBING (TUBING) DIRECTLY TO THE PUMP MAX RATHER THAN THE CANISTER. CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE PUMP MAX; THEREFORE, THE PUMP MAX WAS DISCONNECTED. THE PROCEDURE WAS COMPLETED USING ANOTHER PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10141554 ↗
• MalfunctionJun 3, 2020Misconnection; Device Contamination with Body Fluid; Misconnection; Device Contamination with Body Fluid

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT M1 AND M2 SEGMENTS OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE HOSPITAL STAFF ACCIDENTALLY CONNECTED THE ASPIRATION TUBING (TUBING) DIRECTLY TO THE PUMP MAX RATHER THAN THE CANISTER. CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE PUMP MAX. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH A SYRINGE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10117360 ↗
• MalfunctionApr 22, 2020Decrease in Suction; Decrease in Suction

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE ASPIRATION PRESSURE OF THE PUMP MAX DECREASED; THEREFORE, IT WAS DISCONNECTED. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH A SYRINGE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9988305 ↗
• MalfunctionMar 13, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX) AND A PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETERS (ACE68). DURING THE PROCEDURE, THE PUMP MAX ASPIRATION PRESSURE WOULD NOT INCREASE BEYOND -20 INHG RESULTING IN THE DECREASE OF SUCTION FORCE FOR THE THROMBUS; THEREFORE, THE PUMP MAX WAS REMOVED. IT WAS REPORTED THAT MULTIPLE ATTEMPTS WERE MADE TO TROUBLESHOOT THE PUMP MAX BUT WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH A 60CC SYRINGE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9832356 ↗
• MalfunctionFeb 14, 2020Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE PUMP MAX INTERMITTENTLY STOPPED ASPIRATING; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A PENUMBRA ENGINE (ENGINE). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9714829 ↗
• MalfunctionDec 31, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A FISTULA USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE PUMP MAX WAS LOW, IRREGULAR, AND CONTINUED TO STOP. THE PROCEDURE WAS COMPLETED USING THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9536258 ↗
• MalfunctionDec 31, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE PUMP MAX WAS LOW, IRREGULAR, AND CONTINUED TO STOP. THE PROCEDURE WAS COMPLETED USING THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9536249 ↗
• MalfunctionDec 31, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE PUMP MAX WAS LOW, IRREGULAR, AND CONTINUED TO STOP. THE PROCEDURE WAS COMPLETED USING THE SAME PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9536239 ↗
• MalfunctionNov 5, 2019Misconnection; Device Contamination with Body Fluid; Misconnection; Device Contamination with Body Fluid

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE ASPIRATION TUBING (TUBING) WAS INADVERTENTLY CONNECTED TO THE PUMP MAX RATHER THAN THE PUMP MAX CANISTER (CANISTER). BLOOD WAS THEN ASPIRATED INTO THE PUMP MAX; THEREFORE, THE PUMP MAX WAS REMOVED AND NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER PUMP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280578 ↗
• MalfunctionNov 1, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE PUMP MAX STOPPED WORKING. IT WAS REPORTED THAT THE MOTOR WOULD NOT RUN DESPITE THAT THE PUMP MAX WAS POWERED ON. THEREFORE, THE PUMP MAX WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269667 ↗
• MalfunctionOct 22, 2019Smoking; Suction Problem; Smoking; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE COMMON CAROTID ARTERY (CCA)/RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE PUMP MAX STARTED EMITTING SMOKE AND STOPPED WORKING. THE PHYSICIAN WAS UNABLE TO TURN THE PUMP MAX BACK ON AND THERE WAS NO ASPIRATION. THEREFORE, THE PUMP MAX WAS DISCONNECTED AND THE PROCEDURE WAS COMPLETED USING A MANUAL ASPIRATION WITH A SYRINGE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9221921 ↗
• MalfunctionAug 29, 2019Suction Problem; Suction Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING ASPIRATION, IT WAS REPORTED THAT THE PUMP MAX SUDDENLY STOPPED ASPIRATING. THE PUMP MAX WAS THEREFORE REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8947402 ↗
• MalfunctionJul 22, 2019Power Problem; Power Problem

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V (PUMP MAX). DURING THE PROCEDURE, WHILE CONNECTING THE PUMP TO THE POWER CIRCUIT, A SHORT CIRCUIT OCCURRED CAUSING THE POWER IN THE CATHETERIZATION LABORATORY TO SHUT OFF. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION WITH A SYRINGE TO REMOVE THE CLOT FROM THE MCA. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812270 ↗
• MalfunctionJul 9, 2019Misconnection; Device Handling Problem; Misconnection; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE HOSPITAL STAFF ACCIDENTALLY CONNECTED THE ASPIRATION TUBING (TUBING) DIRECTLY TO THE PUMP MAX RATHER THAN THE CANISTER. CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE PUMP MAX; THEREFORE, THE PUMP MAX WAS DISCONNECTED. THE PROCEDURE WAS COMPLETED USING ANOTHER PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8772809 ↗
• MalfunctionJul 2, 2019Misconnection; Device Handling Problem; Misconnection; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE HOSPITAL STAFF ACCIDENTALLY CONNECTED THE ASPIRATION TUBING (TUBING) DIRECTLY TO THE PUMP MAX RATHER THAN THE CANISTER. CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE PUMP MAX AND IT STOPPED WORKING; THEREFORE, THE PUMP MAX WAS DISCONNECTED. THE PROCEDURE WAS COMPLETED USING ANOTHER PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8753797 ↗
• MalfunctionJun 25, 2019Power Problem; Power Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE ASPIRATION FOR THE PUMP MAX REPEATEDLY STOPPED WORKING, DESPITE THE HOSPITAL STAFF NOT TURNING IT OFF WITH THE POWER BUTTON AND, THEREFORE, THE PUMP MAX WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A DIFFERENT PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8732970 ↗
• MalfunctionMay 28, 2019Misconnection; Device Handling Problem; Misconnection; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220 (PUMP MAX). DURING THE PROCEDURE, THE ASPIRATION TUBING (TUBING) WAS ACCIDENTALLY CONNECTED DIRECTLY TO THE PUMP MAX RATHER THAN THE INDIGO PUMP MAX CANISTER (CANISTER). CONSEQUENTLY, FLUID WAS ASPIRATED INTO THE PUMP MAX AND IT STARTED SMOKING AND SHUT DOWN. THEREFORE, THE PUMP MAX WAS REMOVED. THE PROCEDURE WAS COMPLETED USING MANUAL ASPIRATION. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8645837 ↗
• MalfunctionMay 23, 2019Misconnection; Device Handling Problem; Misconnection; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V (PUMP MAX). DURING THE PROCEDURE, THE ASPIRATION TUBING (TUBING) WAS ACCIDENTLY CONNECTED DIRECTLY TO THE PUMP MAX RATHER THAN THE CANISTER. CONSEQUENTLY, BLOOD WAS ASPIRATED INTO THE PUMP MAX AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PUMP MAX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636715 ↗