Aquilex Fluid Control SystemRecalls & reported problems across all models

We found 4 models of Aquilex Fluid Control System by W.O.M. World of Medicine GmbH in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between May 13, 2019 and Aug 14, 2026 — classified as 1 death, 2 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (11 reports).

2 FDA recall records name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Aquilex Fluid Control System recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 17, 2023Open, Classified

   The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload

   Z-2629-2023 · Root cause: Software design · Recall details · FDA record ↗

2. Aug 14, 2019Terminated

   The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.

   Z-2767-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Aquilex Fluid Control System problems

Aquilex Fluid Control System models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Aquilex® Fluid Control System AQL-100CBS

  Insufflator, Hysteroscopic
  1 recall18 reports
• Aquilex Fluid Control System AQL-100PBS

  Insufflator, Hysteroscopic
  1 recall8 reports
• Aquilex® Fluid Control System AQL-100CS

  Insufflator, Hysteroscopic
  15 reports
• Aquilex® Fluid Control System AQL-100P

  Insufflator, Hysteroscopic
  1 death3 reports

Recent Aquilex Fluid Control System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Measurement System Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50249288 ↗
• MalfunctionOct 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "ISSUE REPORTED: NEGATIVE DEFICIT. TROUBLESHOOTING PERFORMED AND ADDITIONAL DETAILS: THIS SYSTEM GAVE NEGATIVE DEFICIT TODAY. THE REPORTER PERFORMED A SCALE TEST AND EVERYTHING WAS +/- 20 ON THE SCALES EXCEPT THE BAG SCALE READ -5. WHEN REPORTER WAS CALLED TO THE ROOM THE NEGATIVE DEFICIT WAS READING -750 +. SHE ASKED THEM TO NOT RELY ON THE DEFICIT AND TO DO A MANUAL COUNT. HOW DID THE PROCEDURE COMPLETE: USING THIS SYSTEM. PROCEDURE SETTING: CLINICAL. DATE OF PROCEDURE: (B)(6) 2025."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404660 ↗
• MalfunctionOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "ISSUE REPORTED: AT MID-CASE FOR APPROXIMATELY 3 MINUTES, THE DEFICIT WAS SHOWING AS A NEGATIVE NUMBER. TROUBLESHOOTING PERFORMED AND ADDITIONAL DETAILS: RIGHT BEFORE ENDING THE CASE, THE NEGATIVE SIGN WENT AWAY TO SHOW A FINAL POSITIVE DEFICIT. PROCEDURE WAS COMPLETE AND PATIENT WAS UNHARMED. GSS TS CONFIRMED DEFICIT TEST WAS NOT PERFORMED POST OP. CUSTOMER DID NOT CHANGE THE SUPPLY BAG, CANISTER, OR ANY TUBING WHEN THIS EVENT OCCURED. FINAL DEFICIT READING ON PUMP WAS 235MLS; MANUAL COUNT NOT PERFORMED. HOW DID THE PROCEDURE COMPLETE: WITH THE SAME EQUIPMENT PROCEDURE SETTING: CLINICAL DATE OF PROCEDURE: ON (B)(6) 2025."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23308283 ↗
• MalfunctionSep 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "ISSUE REPORTED: NEGATIVE DEFICIT TROUBLESHOOTING PERFORMED AND ADDITIONAL DETAILS: GARREN WAS PRESENT FOR THE PROCEDURE. IT WAS A LONG PROCEDURE USING ABOUT 10 BAGS OF FLUID AND MULTIPLE CANISTERS. THE DEFICIT HELD UP AROUND 1,000 FOR A MAJORITY OF THE CASE. AT THE END OF THE CASE, GARREN CHECKED THE DEFICIT GOING AND THE SYSTEM DISPLAYED - 9,999. THERE WAS NO INJURY TO THE PATIENT AND THE PROCEDURE WAS SUCCESSFUL. HOW DID THE PROCEDURE COMPLETE: USING THIS SYSTEM DATE OF PROCEDURE: ON (B)(6) 2024. THIS SYSTEM IS NOT BEING RETURNED AT THIS TIME." ADDITIONAL INFORMATION Q1: WHICH MEDICAL PROCEDURE HAS BEEN CONDUCTED, E.G. DIAGNOSTIC OR THERAPEUTIC? A1: THERAPEUTIC FIBROID RESECTION MULTIPLE USING Q2: WHAT HAS BEEN DONE, E.G. UTERINE FIBROID REMOVAL? A2: UTERINE FIBROID RESECTION Q3: DID PERFORATION OCCUR? IF YES, WAS IT CONFIRMED USING LAPAROSCOPY? A3: NO Q4: WHICH PRESSURE HAS BEEN USED? A4: 80 & 90 Q5: WHICH DISTENTION MEDIUM HAS BEEN USED? A5: SALINE Q6: WHICH FLUID BAG SIZE WAS USED? A6: 3L Q7: WHICH DEFICIT VALUE WAS DISPLAYED ON THE PUMP AT THE END OF THE PROCEDURE? A7: DO NOT REMEMBER BUT REPORTED IT TO TECHNICAL SUPPORT Q8: WHIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20319921 ↗
• MalfunctionSep 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "THE DEFICIT STOPPED RECORDING HALF WAY THROUGH THE PROCEDURE USING XL MYOSURE DEVICE. THE CUSTOMER HUNG A TOTAL OF (16), 3L SALINE BAGS (TOTAL OF 48,000MLS) TO REMOVE A VERY LARGE FIBROID. THE DR. USED 3-4 MYOSURE XL DEVICES. THE CUSTOMER HAD TO USE 16-17 CANISTERS THROUGHOUT THE PROCEDURE. TROUBLESHOOTING: ONCE DEFICIT STOPPED ON 0MLS, THE CUSTOMER CONTINUED USING THE SYSTEM BUT USED MANUAL COUNT. THE TM EXPLAINED THE CUSTOMER SUCTIONED ABOUT 400CC?S FROM THE UNDER BUTTOCKS DRAPE. AFTER THE PROCEDURE CUSTOMER PRESSED UP AND DOWN ARROWS TO SHOW THE AMOUNT OF FLUID USED DURING THE PROCEDURE AND SCREEN SHOWED 0MLS. MANUAL COUNT BY REP WAS 800MLS BUT THE DR. RECORDED 200MLS FOR DEFICIT FOR THERE WAS A LOT OF FLUID ON THE FLOOR. ADDITIONAL INFORMATION APPS SPEC EXPLAINED THERE IS A SOFTWARE ANOMALY WITH THE AQL-100PBS. APPS SPEC EXPLAINED THAT ONCE TOTAL FLUID EQUALS 30,000MLS, THE DEFICIT WILL START TO COUNT BACKWARD TO ZERO. IT IS RECOMMENDED TO PERFORM A MANUAL COUNT GOING FORWARD. APPS SPEC STATED: ? BE COGNIZANT WHEN YOU HANG YOUR TENTH 3,000 LITER BAG? ONCE THE SYSTEM FULLY DEPLETES THAT TENTH BAG THE INFLOW COUNT WILL HIT 30,000 WHI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736008 ↗
• DeathAug 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TECHNICAL SUPPORT WAS CONTACTED BY A. MIRANTE - TERRITORY MANAGER TM WHO REPORTED THAT HE WAS PRESENT FOR A TISSUE REMOVAL PROCEDURE USING MYOSURE AND AQUILEX. THE PROCEDURE WAS GOING NORMAL THE DEFICIT WAS STEADY AT 1000-1300 AND WOULD INCREASE SLIGHTLY WHILE REMOVING THE TISSUE. THE DOCTOR THEN THOUGHT SHE SAW SOMETHING THAT LOOKED LIKE A PERFORATION. AT THAT POINT THE DEFICIT WAS INCREASING QUICKLY, AT 2500 THE DOCTOR STOPPED THE PROCEDURE. THE TM THEN LEFT THE ROOM SINCE THE DOCTOR MENTIONED THAT THEY WERE GOING TO DO AN ECHOCARDIOGRAM ON THE PATIENT ALONG WITH SOME OTHER TESTS. THIS PROCEDURE TOOK PLACE AROUND 9 AM AND LATER IN THE DAY HE RECEIVED A CALL FROM THE DOCTOR TELLING HIM THAT THE PATIENT HAD PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN. MYOSURE - CASE: (B)(4)."

  Patient problems: Uterine Perforation

  MAUDE report 17570491 ↗
• MalfunctionJul 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "THE FLUID DEFICIT DROPPED FROM 1700 TO 0 INSTANTLY WITHOUT HAVING COLLECTED THAT AMOUNT FROM THE UNDERBUTTOX DRAPE AS THERE WAS NONE PRESENT AT THAT TIME. (B)(6) WAS PRESENT IN THE ROOM AND THE SCALES HAD NOT BEEN TOUCHED, A CANISTER WAS NOT BEING CHANGED AND A SALINE BAG WAS NOT BEING HUNG AT THAT TIME. THE PHYSICIAN ENDED THE CASE WITH THE LAST RECORDED DEFICIT OF 1700 AND CHOSE NOT TO MOVE FORWARD. PATIENT STATUS: NO INJURY REPORTED, NO EXTENDED HOSPITAL STAY OR ADDITIONAL TREATMENT NEEDED. ADDITIONAL INFORMATION: TECH SUPPORT IS CONFIRMING THE SYSTEM IS FUNCTIONING CORRECTLY"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414095 ↗
• MalfunctionJun 8, 2023Calibration Problem; Calibration Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "PROBLEM DESCRIPTION PROBLEM DESCRIPTION CALLER: HOLOGIC EMPLOYEE (TM) NAME: (B)(6). PART SHIP DATE: (B)(6) 2022. DATE OF PROCEDURE: (B)(6) 2023. DATE PRODUCT SUPPORT OR HOLOGIC EMPLOYEE NOTIFIED OF ISSUE REPORTED: 5/4/2023. ISSUE REPORTED: NEGATIVE DEFICIT. TROUBLESHOOTING PERFORMED: PERFORMED A MANUAL COUNT. DR. WHO PERFORMED THE PROCEDURE: UNKNOWN. PATIENT STATUS: NO INJURY REPORTED OR PAE. REPLACEMENT REQUESTED: YES. IS PRODUCT RETURNING FOR INVESTIGATION: YES. DETAILED DESCRIPTION: THOMAS REPORTS THAT DURING A PROCEDURE TODAY, THE DEFICIT SUDDENLY DROPPED AND WENT DOWN TO -300 AND CONTINUED TO DROP. A MANUAL COUNT WAS REQUIRED TO COMPLETE THE CASE. THOMAS ALSO REPORTS THAT SIMILAR ISSUES HAVE HAPPENED IN OTHER CASES, HOWEVER HE DOES NOT KNOW SPECIFIC NUMBERS. THOMAS WAS PRESENT FOR THE CASE TODAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090023 ↗
• InjuryJun 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "TM STATES THAT THE PATIENT WAS GOING THROUGH A MYOSURE/AQUILEX PROCEDURE AND THERE WAS A FLUID OVERLOAD. TM DOES NOT HAVE INFO ON WHICH MYOSURE DEVICE OR SN FOR AQUILEX SYSTEM. TM STATES THAT THE AQUILEX SYSTEM HAD A DEFICIT OF 6000 BUT THE MANUAL COUNT SHOWED 600. PATIENT IS BEING KEPT AT THE HOSPITAL DUE TO PULMINARY EDEMA."

  Patient problems: Pulmonary Edema

  MAUDE report 17078090 ↗
• MalfunctionMay 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "BRIEF DESCRIPTION: INCORRECTLY CALCULATING DEFICIT PROBLEM DESCRIPTION. PROBLEM DESCRIPTION CALLER: HOLOGIC EMPLOYEE NAME: (B)(6) FOR ACCOUNT (IF NOT REPORTER): (B)(6) PART REPORTING DESCRIPTION: AQL-100P DATE PRODUCT SUPPORT OR HOLOGIC EMPLOYEE NOTIFIED OF ISSUE REPORTED: (B)(6). DATE OF PROCEDURE: (B)(6) 2023. ISSUE REPORTED: INCORRECTLY CALCULATING DEFICIT. TROUBLESHOOTING PERFORMED: CUSTOMER REPORTS THAT SYSTEM IS INCORRECTLY CALCULATING DEFICIT. NO FURTHER. INFORMATION IS AVAILABLE. PATIENT STATUS: NO INJURY REPORTED OR PAE . DR. WHO PERFORMED THE PROCEDURE: UNKNOWN. HOW DID THE PROCEDURE COMPLETE: UNKNOWN. PATIENT/USER IMPACT: NO IMPACT REPORTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16944917 ↗
• MalfunctionDec 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Output Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "BRIEF DESCRIPTION: DEFICIT READINGS GOING TO NEGATIVE. PROBLEM DESCRIPTION: REPORTER: (B)(6). PART DESCRIPTION: AQUILEX SCALE. SERIAL NUMBER OR LOT NUMBER OF REPORTED ITEM: (B)(4). DATE PRODUCT SUPPORT OR HOLOGIC EMPLOYEE NOTIFIED OF ISSUE REPORTED: (B)(6) 2022. ISSUE REPORTED: DEFICIT READINGS GOING TO NEGATIVE. REPLACEMENT REQUESTED: YES. IS PRODUCT RETURNING FOR INVESTIGATION: YES. ADDITIONAL PROCEDURE INFORMATION: TECHNICAL SUPPORT WAS CONTACTED BY (B)(6) WHO REPORTED THAT THE CUSTOMER JUST RECEIVED THIS SYSTEM LAST MONTH AND ARE HAV-ING ISSUES WHERE THE DEFICIT READING WILL GO TO NEGATIVE READING RANDOMLY. A REPLACEMENT IS REQUESTED FOR THE CUSTOMER. A REPLACEMENT SYSTEM IS BEING SENT ATTN -PR. (B)(4). PATIENT/USER IMPACT: NO IMPACT REPORTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995176 ↗
• MalfunctionOct 4, 2022False Negative Result; Output Problem; False Negative Result; Output Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING NOTIFICATION OF RECEIVED HOSPITAL REPORTS FROM HEALTH (B)(6): "AQUILEX MACHINE BME1139 MALFUNCTIONED DURING PROCEDURE. FOLLOWING CANNISTER CHANGE AQUILEX MACHINE SHOWED NEGATIVE DEFICIT OF -120 AND SECONDS LATER SHOWED NEGATIVE DEFICIT OF -395 AND QUICKLY ESCALATED TO -450 MLS OF SODIUM CHLORIDE. DR. MADE AWARE AT THIS TIME AND AN IN AND OUT FLUID BALANCE WAS DONE AND DETERMINED AT THAT TIME TO BE OF NO DEFICIT. REP FOR THE AQUILEX MACHINE WAS CALLED AT THIS TIME AND WAS AVAILA-BLE ONLY BY PHONE. HE WAS UNABLE TO DETERMINE WHY THE MACHINE WAS GIVING THIS NEGATIVE DEFICIT VALUE. PROCEDURE FOR FLUID BAG CHANGE AND CANNISTER CHANGE DONE AS ACCORDING TO MANUFACTURER'S SUGGESTION AND AS STATED BY EQUIPMENT REP. DURING SECOND CANNISTER CHANGE THE FLUID BALANCE QUICKLY WENT TO -50. HIGH FLUID LOSS ALARMED AT THIS TIME AND THE DEFICIT WENT BACK DOWN TO -5 MLS. DURING THE CASE SURGEON NOTIFIED OF FLUID DEFICIT BY NURSES IN THE ROOM ACCORDING TO BAGS IN AND CANNISTERS OUT. NOTIFIED AT 500 MLS, 800 MLS, 1500 MLS, 2100 MLS, 2400 MLS AND FINAL 2800 MLS" ADDITIONAL INFORMATION RECEIVED: "(B)(6) 2022 TECH SUPPORT REACHED OUT TO THE CUSTOMER J.P. REQUESTING A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535228 ↗
• MalfunctionSep 24, 2022Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: "(B)(4): BRIEF DESCRIPTION. DEFICIT DROPPED TO -999 DURING PROCEDURE. PROBLEM DESCRIPTION REPORTER: (B)(6), PART RETURNING DESCRIPTION: DATE OF PROCEDURE: (B)(6) 2022, DATE PRODUCT SUPPORT OR HOLOGIC EMPLOYEE NOTIFIED OF ISSUE REPORTED: (B)(6) 2022, ISSUE REPORTED: DEFICIT DROPPED TO -999 DURING PROCEDURE . TROUBLESHOOTING PERFORMED: DURING A HYSTEROSCOPY, THE DEFICIT SUDDENLY DROPPED TO -999. THE PROCEDURE WAS ABORTED SHORTLY AFTER AS THE SURGEON PERFORATED WITH THE SCOPE (CASE 01120410). THIS DEFICIT ISSUE HAS HAPPENED IN A PREVIOUS CASE (CASE 01095004) WHERE THE DEFICIT SUDDENLY DROPPED FROM 2000 TO 200. NONE OF THE BAGS OR CANISTERS WERE BEING TOUCHED WHEN THIS HAPPENED. THE SYSTEM WAS FACING AWAY FROM V. AT THE TIME OF DEFICIT CHANGE, V. WAS NOTIFIED BY A SCRUB TECH THAT IT HAPPENED. POWER CABLE WAS NOT DRAPED OVER SYSTEM OR CANISTERS DURING PROCEDURE. THE DEFICIT CHANGED AFTER THE PERFORATION OCCURRED, HOWEVER V. STATES THE PROCEDURE WAS VERY QUICK. V. DID DEFICIT/FLOW RATE TESTS AND SCALE TEST, AND THE SYSTEM PASSED. HOW DID THE PROCEDURE COMPLETE: ABORTED . PATIENT STATUS: NO INJURY REPORTED OR P.AE. DR. WHO PERFORMED THE PROCED

  Patient problems: Insufficient Information

  MAUDE report 15476431 ↗
• MalfunctionSep 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  WE HAVE BEEN INFORMED OF THE FOLLOWING EVENT: FOLLOW UP CALLED IN YESTERDAY - AQL DEFICIT ISSUES. REPORTER: (B)(6) FOR ACCOUNT (IF NOT REPORTER): PART RETURNING DESCRIPTION: RM-AQL-100PBS SERIAL NUMBER OF REPORTED ITEM: (B)(4).. DATE PRODUCT SUPPORT OR HOLOGIC EMPLOYEE NOTIFIED OF ISSUE REPORTED: (B)(6) 2022. ISSUE REPORTED: DEFICIT-80ML. TROUBLESHOOTING PERFORMED: (B)(6) EXPLAINED THAT THE CUSTOMER RAN INTO A FINAL DEFICIT OF -80ML IN A RECENT PROCEDURE (FINDING OUT DATE). (B)(6) ADVISED TO RUN A FLUID DEFICIT TEST. (B)(6)EXPLAINED THAT THIS ALSO HAD A -80ML FINAL READING. (B)(6) WILL ALSO RUN A SCALE TEST TO CONFIRM A DAMAGED SCALE. SENT (B)(6) THE DEFICIT QUESTIONS. WAITING ON REPLY. HOW DID THE PROCEDURE COMPLETE: YES. PATIENT STATUS: NO. INJURY REPORTED OR PAE. DR. WHO PERFORMED THE PROCEDURE: UNKNOWN. REPLACEMENT REQUESTED: Y. IS PRODUCT RETURNING FOR INVESTIGATION: UNSURE. PATIENT/USER IMPACT NO IMPACT REPORTED. 08.09.2022 ADDITIONAL INFORMATION FROM HOLOGIC: THE CASE WAS CLOSED FOR OUR CUSTOMER SERVICE DEPARTMENT SINCE UNFORTUNATELY, WE COULDN'T GET ANY ANSWER BACK FROM CUSTOMER AFTER 3 ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427884 ↗
• MalfunctionAug 9, 2022Application Program Problem; Application Program Problem

  WE HAVE BEEN INFORMED OF THE FOLLOWIND EVENT: "PART DESCRIPTION: AQL PBS SERIAL NUMBER OR, LOT NUMBER OF REPORTED ITEM: 1911CE1150 , DATE OF PROCEDURE: (B)(6) 2022, DATE PRODUCT SUPPORT OR HOLOGIC EMPLOYEE NOTIFIED OF ISSUE REPORTED: (B)(6) 2022, ISSUE REPORTED: CUSTOMER CALLED TM EXPLAINING THAT DURING A PROCEDURE, THE DEFICIT JUMPED FROM 2000MLS DOWN TO 200MLS. TM STATED THE FLUID DEFICIT TEST PASSED AFTER CHECKING POST OP. THE CUSTOMER STATED 19+ SALINE BAGS WERE USED IN THE 2-HOUR PROCEDURE. THE CUSTOMER LEFT ALL FLUID BAGS ON THE HOOKS AND DID NOT LIFT ANY BAGS WHILE REPLACING DURING PROCEDURE. THE CUSTOMER ALSO CLAIMED THE DEFICIT WENT NEGATIVE AT SOME POINT DURING THE PROCEDURE. TROUBLESHOOTING PERFORMED: NO INFORMATION PROVIDED HOW DID THE PROCEDURE COMPLETE: DESPITE THE INACCURACIES OF THE DEFICIT, THE PROCEDURE COMPLETED WITHOUT INJURY. PATIENT STATUS: NO INJURY REPORTED. REPLACEMENT REQUESTED: N. LETTER OF INVESTIGATION REQUESTED: N. IS PRODUCT RETURNING FOR INVESTIGATION: N. SITE CONTACT INFORMATION: NA. ADDITIONAL INFORMATION: APPS SPEC CONFIRMED MANUAL COUNT WAS 1500MLS AND PRESSURE WAS SET TO 80MMHG THROUGHOUT THE PROCEDURE. THE MEAN ARTERIAL PRESSURE (MAP) IS UNKNOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189747 ↗

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