Prometra II Pump 13827Recalls & reported problems

Summary

The FDA's MAUDE database contains 859 adverse event reports that list this exact device (DI 00810335020228), received between Sep 2, 2015 and Jan 27, 2026 — classified as 40 deaths, 729 injuries, 90 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (213 reports).

13 other recalls cover devices cleared under the same FDA submission (P080012); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 859 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2026Communication or Transmission Problem; Insufficient Device Problem Information

  PHYSICIAN CONTACTED SENIOR CLINICAL ENGINEER (SCE) TO REPORT A PROMETRA II 20 ML PUMP THAT IS UNABLE TO COMMUNICATE WITH A PROGRAMMER ON JANUARY 22, 2026. HE REPORTS THAT HE WAS ABLE TO PERFORM AN INITIAL INQUIRY, BUT SUBSEQUENT REPEATED EFFORTS SHOWED "PUMP COMMUNICATION FAILED". SCE ASKED IF THE PHYSICIAN COULD HEAR THE AUDIBLE TONE THE PROGRAMMER MAKES WHEN ATTEMPTING TO CONNECT AND THE PHYSICIAN SAID YES. SCE THEN REQUESTED THE PHYSICIAN PERFORM A POWER CYCLE ON THE PROGRAMMER AND TO CHANGE THE BATTERIES, BUT THOSE EFFORTS WERE UNSUCCESSFUL. SCE ASKED THE PHYSICIAN TO USE ANOTHER PROGRAMMER BUT THESE EFFORTS WERE ALSO UNSUCCESSFUL. AT THIS POINT, SCE RECOMMENDED A PUMP REPLACEMENT. THE PUMP HAS ALREADY BEEN EXPLANTED, REPLACED, AND DISCARDED. NO INVESTIGATION IS POSSIBLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24194248 ↗
• InjuryJan 27, 2026Improper Flow or Infusion; Insufficient Device Problem Information

  HEALTHCARE PROFESSIONAL CONTACTED THE SENIOR CLINICAL ENGINEER (SCE) REGARDING A PATIENT'S PUMP THAT WAS SHOWING SLIGHTLY MORE MEDICATION LEFT IN THE PUMP THAN EXPECTED. THE NURSE STATED THAT THE PATIENT WAS NOT ALLEGING ANY NEGATIVE SYMPTOMS, BUT THAT THE PUMP IS SCHEDULED FOR EXPLANT ON (B)(6) 2025, SINCE THERE WERE A COUPLE MORE MLS OF MEDICATION PULLED OUT THAN WAS EXPECTED. SCE WALKED THE REPORTER THROUGH SEVERAL TROUBLESHOOTING STEPS, INCLUDING A DYE STUDY TO DETERMINE IF THERE WAS AN OCCLUSION OR A KINK. HOWEVER, THE PHYSICIAN ASSOCIATED WITH THE CASE REPORTED THAT THAT WOULD NEED TO BE PERFORMED BY THE MANAGING PHYSICIAN AND AS THE SURGEON, THEY WILL ONLY DO EITHER A REVISION OR AN EXPLANT. THE EXPLANT IS SCHEDULED FOR (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189755 ↗
• InjuryJan 27, 2026Improper Flow or Infusion

  PHYSICIAN CONTACTED THE SENIOR CLINICAL ENGINEER (SCE) REGARDING A PATIENT'S PUMP THAT WAS SHOWING MORE MEDICATION LEFT IN THE PUMP THAN EXPECTED. THE PHYSICIAN REPORTS THAT THE PATIENT WAS COMPLAINING OF WITHDRAWAL SYMPTOMS AND WHEN HE BROUGHT THE PATIENT IN, THERE WERE SEVERAL MORE MLS OF MEDICATION PULLED OUT THAN WAS EXPECTED. SCE WALKED THE PHYSICIAN THROUGH SEVERAL TROUBLESHOOTING STEPS, INCLUDING A DYE STUDY TO DETERMINE IF THERE WAS AN OCCLUSION OR A KINK. HOWEVER, THE PHYSICIAN REPORTED THAT THE PATIENT IS DECLINING ALL TROUBLESHOOTING MEASURES AND REQUESTING AN EXPLANT. THE EXPLANT IS SCHEDULED FOR (B)(6) 2025.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24189205 ↗
• InjuryOct 30, 2025Improper Flow or Infusion; Improper Flow or Infusion

  PATIENT CONTACTED THE SENIOR CLINICAL ENGINEER (SCE) REGARDING THE EXPLANT OF THEIR IMPLANTED PUMP SCHEDULED FOR (B)(6) 2025. THE CALLER REPORTS THAT ON (B)(6) 2025, A REFILL WAS PERFORMED BY THE PHYSICIAN ASSISTANT AT THEIR TYPICAL PAIN PRACTICE. THE PATIENT REPORTS TASTING AND SMELLING METALLIC SHORTLY AFTER THE FILL AND GROWING MORE LETHARGIC WITH BACK SPASMS OVER THE NEXT TWO DAYS, LEADING TO THE FIRST OF THREE EMERGENCY ROOM VISITS OVER THE SUBSEQUENT 4 DAYS, BEGINNING ON (B)(6) 2025. UPON INQUIRY AT THE ER, NO PUMP ERRORS OR OTHER ISSUES WERE OBSERVED WITH THE PUMP. DUE TO THE NATURE OF THE SYMPTOMS, THE SCE WALKED THE CALLER THROUGH THE PROPER TECHNIQUE FOR PERFORMING REFILLS: INJECT IN 1ML, WAIT FOR ASPIRATION BACK, PUSH 5 MLS, WAIT FOR 1ML, PUSH 5ML, REPEAT UNTIL FULLY REFILLED) AND THE CALLER DESCRIBED THAT THE PA DID NOT SEEM TO FOLLOW THIS PROCEDURE. SCE THEN EXPLAINED WHAT A POCKET FILL ENTAILS AND SUGGESTED A CONFERENCE WITH THE PHYSICIAN TO DISCUSS NEXT STEPS OR TRAINING FOR REFILLS. HOWEVER, THE PATIENT INFORMED SCE THAT THE PHYSICIAN IS SET ON HAVING THE PUMP REPLACED WITH A MEDTRONIC PUMP DURING THE FOLLOWING WEEK ON (B)(6) WITH NO DESIRE TO TROUBLE SHOOT. AS OF J

  Patient problems: Inadequate Pain Relief

  MAUDE report 23426749 ↗
• InjuryMar 19, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  REPORTER CONTACTED PATIENT TRACKING THROUGH EMAIL REPORTING A PUMP REPLACEMENT DUE TO UNDERINFUSION VOLUME DISCREPANCIES AND THE PATIENT EXPERIENCING A DECREASE IN PAIN THERAPY. REPORTER CONFIRMED THAT A CATHETER DYE STUDY WAS PREVIOUSLY PERFORMED WHICH CONFIRMED THAT THE CATHETER WAS PATENT. ADDITIONALLY, THE PATIENT'S PUMP WAS DISCARDED AFTER REPLACEMENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18933856 ↗
• MalfunctionJan 16, 2024Battery Problem; Battery Problem

  AGENT CONTACTED THE DIRECTOR OF CLINICAL ENGINEERING (DCE) TO REPORT A PATIENT'S PUMP THAT WAS SHOWING THAT ITS BATTERY WAS LOW. THE AGENT REPORTED THAT THE LOW BATTERY MESSAGE WAS OBSERVED SEVERAL TIMES. DURING AN ATTEMPT TO RESET THE PUMP, THE CLINICIAN PROGRAMMER LOST CONNECTION TO THE PATIENT'S PUMP AND SUBSEQUENT ATTEMPTS TO INQUIRE THE PUMP WERE NOT SUCCESSFUL. THE PATIENT DID NOT ALLEGE ANY SYMPTOMS OF WITHDRAWAL BUT IT IS BELIEVED THAT THE PUMP IS NOT FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522179 ↗
• InjuryJan 9, 2024Battery Problem; Battery Problem

  PATIENT TRACKING RECEIVED AN EMAIL REPORTING A REPLACEMENT SURGERY DUE TO THE PATIENT'S PUMP BEING DEAD AND A LOW BATTERY ALARM SOUNDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475728 ↗
• InjuryJan 8, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  PATIENT TRACKING RECEIVED A REPLACEMENT TRACKING FORM THROUGH EMAIL REPORTING A PUMP SYSTEM REPLACEMENT. ADDITIONAL FOLLOW UP WILL BE PERFORMED TO DETERMINE THE REASON FOR REPLACEMENT. NURSE CONFIRMED THAT THE PATIENT'S PUMP SYSTEM WAS EXPLANTED DUE TO UNRELIEVED SPASTICITY AS WELL AS PAST UNDERINFUSION VOLUME DISCREPANCIES.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 18466457 ↗
• InjuryOct 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT TRACKING RECEIVED A TRACKING FORM REPORTING A PUMP RELOCATION SURGERY THAT WAS PERFORMED DUE TO THE PUMP FLIPPING TOO OFTEN. THE PUMP WAS MOVED FROM THE PATIENT'S ABDOMEN TO THE PATIENT'S BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912152 ↗
• MalfunctionSep 13, 2023Pumping Stopped; Pumping Stopped

  REPORTER FROM A PHYSICIAN'S OFFICE CONTACTED TECHNICAL SOLUTIONS REGARDING A PATIENT'S PUMP THAT WAS NOT COMMUNICATING WITH THEIR PROGRAMMER. TECHNICAL SOLUTIONS ASKED THE REPORTER TO POWER-CYCLE THE PROGRAMMER AND REINQUIRE THE PUMP. THE REPORTER STATED THAT AFTER INQUIRING, ERROR CODES 100, 114 AND 115 WERE OBSERVED. THE REPORTER STATED THAT THE PUMP'S BATTERY LEVEL WAS OKAY WHEN IT WAS LAST INQUIRED. TECHNICAL SOLUTIONS ADVISED THE REPORTER THAT A PUMP EXPLANT WAS RECOMMENDED FOR THIS ISSUE. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736976 ↗
• InjuryAug 3, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  NURSE FROM PHYSICIAN'S OFFICE CONTACTED TECHNICAL SOLUTIONS REGARDING A PATIENT WHO HAD EXPERIENCED A VOLUME DISCREPANCY. THE NURSE REPORTED THAT THE EXPECTED VOLUME WAS 7ML, BUT THEY WERE UNABLE TO ASPIRATE ANY VOLUME FROM THE PUMP. THE NURSE REPORTED THAT THE PATIENT DID NOT SHOW ANY SYMPTOMS ASSOCIATED WITH THE DISCREPANCY. TECHNICAL SOLUTIONS DISCUSSED THE POTENTIAL CAUSES OF OVERINFUSION VOLUME DISCREPANCIES WITH THE NURSE. THE NURSE STATED THAT THE PHYSICIAN WAS NOT COMFORTABLE WITH REFILLING THE PATIENT'S PUMP AT THAT TIME. TECHNICAL SOLUTIONS SUGGESTED THAT THE PHYSICIAN FILL THE PATIENT'S PUMP WITH SALINE AND TO BRING THE PATIENT BACK IN A WEEK TO PERFORM A VOLUME CHECK TO CONFIRM FUNCTIONALITY OF THE DEVICE. LATER COMMUNICATION WITH THE NURSE CONFIRMED THAT THE PHYSICIAN DECIDED TO FORGO TROUBLESHOOTING STEPS AND PERFORMED A PUMP REPLACEMENT SURGERY INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17453372 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A PUMP REPLACEMENT SURGERY. DURING FOLLOW UP COMMUNICATION WITH THE AGENT COVERING THE SURGERY, IT WAS CONFIRMED THAT THE PATIENT'S ORIGINAL PUMP HAD BEEN EXPLANTED "LONG AGO DUE TO A POSSIBLE INFECTION."

  Patient problems: Unspecified Infection

  MAUDE report 17389239 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A PUMP REPLACEMENT SURGERY. ADDITIONAL FOLLOW-UP COMMUNICATION WITH THE AGENT COVERING THE ISSUE CONFIRMED THAT THE PATIENT'S ORIGINAL PUMP HAD BEEN REPLACED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17187497 ↗
• InjuryJun 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PHYSICIAN CONTACTED TECHNICAL SOLUTIONS REPORTING A PATIENT THAT WAS ADMITTED TO THE HOSPITAL. TECHNICAL SOLUTIONS ASKED THE PHYSICIAN IF THE PATIENT WAS HOSPITALIZED DUE TO AN ALLEGED OVERMEDICATION OR UNDERMEDICATION. THE PHYSICIAN REPORTED THAT THE PATIENT HAD GONE TO A SMALL RURAL HOSPITAL AND WERE UNABLE TO DETERMINE THE CAUSE. THE PHYSICIAN REPORTED THAT THE HOSPITAL HAD ADMINISTERED SEVERAL DOSES OF NARCAN TO "LITTLE EFFECT", AND THE PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION. THE PATIENT WAS DISCHARGED THE NEXT MORNING. THE PHYSICIAN REPORTED THAT THE PATIENT WOULD BE VISITING THEIR OFFICE FOR A FOLLOW-UP APPOINTMENT. TECHNICAL SOLUTIONS ASKED THE PHYSICIAN TO ANALYZE THE PUMP BY PERFORMING A VOLUME CHECK. THE PHYSICIAN REPORTED THAT IF THEY DID NOT CALL BACK TO TECHNICAL SOLUTIONS, IT WAS BECAUSE THE PHYSICIAN DEEMED THE PUMP AS FUNCTIONING CORRECTLY AND NO FURTHER ASSISTANCE FROM TECHNICAL SOLUTIONS WOULD BE REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 17174992 ↗
• InjuryJun 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PUMP WAS RECEIVED WITH NO FURTHER INFORMATION. POST MARKET REACHED OUT TO THE PATIENT'S PAIN MANAGEMENT PHYSICIAN'S OFFICE AND WAS REFERRED TO AN OFFICE REPRESENTATIVE. A MESSAGE WAS LEFT FOR THAT REPRESENTATIVE REQUESTING FURTHER INFORMATION. VOLUNTARY MW5117872 WAS RECEIVED STATING: "PT HAD A FLOWONIX INTRATHECAL PAIN PUMP. IT IS A FLOWONIX PROMETRA II 20ML PUMP. THIS PUMP HAD INTRATHECAL HYDROMORPHONE 15 MG/ML AND INTRATHECAL BACLOFEN 500 MCG/ML RUNNING AT 3.6 MG/DAY OF HYDROMORPHONE AND 120 MCG/DAY OF BACLOFEN. THIS PATIENT HAD SUDDEN ONSET OF WITHDRAWAL SYMPTOMS INCLUDING INCREASED PAIN, ANXIETY, YAWNING, DIARRHEA, DRY MOUTH AND PALPITATIONS. THEY PRESENTED TO THE EMERGENCY ROOM WITH WORSENING SYMPTOMS. THEY WERE DIAGNOSED WITH ACUTE WITHDRAWAL SYMPTOMS AND GIVEN ORAL DILAUDID AND BACLOFEN. THE PATIENT PRESENTED TO THE PAIN CLINIC WHERE THEY WERE STILL EXHIBITING WITHDRAWAL SYMPTOMS OF ANXIETY, DIARRHEA, PAIN, PALPITATIONS, NAUSEA AND DEHYDRATION. PHYSICIAN DID A CATHETER DYE STUDY AND FOUND THE CATHETER TO BE PATENT AND IN PROPER POSITION IN THE INTRATHECAL SPACE. PHYSICIAN ALSO INTERROGATED THE PUMP WITH NO ERRORS REPORTED. BASED ON THE PATIENT'S WORSENING WITHDRAWAL SYMPTOM

  Patient problems: Anxiety; Diarrhea; Dry Mouth; Inadequate Pain Relief

  MAUDE report 17118137 ↗
• InjuryJun 5, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A PUMP REPLACEMENT. THE REASON FOR REPLACEMENT WAS REPORTED TO BE A LACK OF SUFFICIENT PAIN RELIEF. ADDITIONAL COMMUNICATION CONFIRMED THAT THERE WAS ALSO AN UNDERINFUSION VOLUME DISCREPANCY OBSERVED. THE VOLUMES ASSOCIATED WITH THE ALLEGED DISCREPANCY WERE NOT AVAILABLE. THE EXPLANTED DEVICE WAS DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17060627 ↗
• InjuryMay 26, 2023Use of Device Problem; Use of Device Problem

  PHYSICIAN CONTACTED TECHNICAL SOLUTIONS AFTER THEIR PATIENT HAD BEEN IN THE ICU OVERNIGHT AFTER A REFILL APPOINTMENT. PHYSICIAN REPORTED THAT THEIR STAFF MEMBER HAD PERFORMED A REFILL THE DAY PRIOR AND EVERYTHING APPEARED WELL. HOWEVER, SHORTLY AFTER PROGRAMMING THE REFILL, IT WAS REPORTED THAT THE PATIENT BEGAN DECOMPENSATING RAPIDLY. PHYSICIAN REPORTED THAT THE PATIENT HAD SYMPTOMS OF A FENTANYL OVERDOSE, INCLUDING CHEST RIGIDITY. NARCAN HAD TO BE ADMINISTERED BY THE PHYSICIAN'S TEAM BEFORE EMTS ARRIVED ON SCENE. PHYSICIAN STATED THAT THEY ACCESSED THE POCKET AND WERE ABLE TO PULL ROUGHLY 8ML OF MEDICATION. THE PUMP WAS NOTED TO CONTAIN 10ML. THE PHYSICIAN REMOVED THE MEDICATION AND PUSHED IN 10CC OF PF SALINE TO DETERMINE IF THE PUMP WAS FUNCTIONAL. THEY ASPIRATED ALL 10CC AFTER TWO SALINE FLUSHES. PHYSICIAN PUT THE MEDICATION BACK INTO THE PUMP BUT SHUT THE PUMP OFF PRIOR TO THE PATIENT BEING TAKEN TO THE HOSPITAL. THE PHYSICIAN REPORTED THAT AFTER DETERMINING IT WAS A POCKET FILL, THEY WOULD BE GOING TO THE HOSPITAL TO TURN THE PUMP BACK ON TO PREVENT WITHDRAWAL. LATER COMMUNICATION WITH AN OFFICE REPRESENTATIVE CONFIRMED THAT THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL

  Patient problems: Muscular Rigidity

  MAUDE report 17010084 ↗
• InjuryMay 23, 2023Insufficient Flow or Under Infusion; Obstruction of Flow; Insufficient Flow or Under Infusion; Obstruction of Flow

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A PUMP REPLACEMENT SURGERY. THE REASON FOR SURGERY WAS REPORTED TO BE, "NO ASPIRATION; PUMP WOULD NOT FLOW." THE DEVICE WAS DISCARDED AFTER SURGERY. ADDITIONAL COMMUNICATION WITH THE AGENT COVERING THE ISSUE CONFIRMED THAT A CAP STUDY WAS PERFORMED, DURING WHICH THE LACK OF ASPIRATION AND FLOW WAS OBSERVED. THE PATIENT HAD REPORTED A LOSS OF THERAPY. THE AGENT ALSO REPORTED THAT AN UNDER INFUSION VOLUME DISCREPANCY WAS OBSERVED, ALTHOUGH NO ADDITIONAL INFORMATION WAS AVAILABLE ABOUT THIS DISCREPANCY. WHEN THE PHYSICIAN REMOVED THE CATHETER FROM THE PATIENT'S PUMP DURING SURGERY, THE METAL PUMP STEM REPORTEDLY DISLODGED FROM THE OUTER SILICONE STEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16984682 ↗
• InjuryMay 19, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A PUMP REPLACEMENT. THE REASON FOR REPLACEMENT WAS REPORTED TO BE A VOLUME DISCREPANCY WHILE THE CATHETER WAS REPORTED TO BE PATENT. THE DEVICE WAS REPORTED TO BE DISCARDED. ADDITIONAL COMMUNICATION WITH THE AGENT COVERING THE ISSUE CONFIRMED THAT THERE WAS AN UNDERINFUSION VOLUME DISCREPANCY OBSERVED IN WHICH THE EXPECTED VOLUME WAS 6ML AND THE ACTUAL ASPIRATED VOLUME WAS 10ML. THE AGENT ALSO REPORTED THAT THE PATIENT HAD ALLEGED A LOSS OF THERAPY. AGENT ALSO CONFIRMED THAT THE CATHETER WAS CONFIRMED TO BE PATENT BY ACCESSING THE CATHETER ACCESS PORT IN ADDITION TO UTILIZING THE CATHETER NEEDLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16963607 ↗
• InjuryMay 17, 2023Use of Device Problem; Use of Device Problem

  PHYSICIAN CONTACTED TECHNICAL SOLUTIONS AFTER A PATIENT WAS ADMITTED TO THE ER WITH A LOSS OF CONSCIOUSNESS FOLLOWING A REFILL APPOINTMENT BY THEIR NURSE. THE DOCTOR CONTACTED TECHNICAL SOLUTIONS LOOKING FOR A REPRESENTATIVE TO INQUIRE THE PUMP TO SEE IF IT WAS MALFUNCTIONING. TECHNICAL SOLUTIONS ASKED FOR MORE INFORMATION AND THE DOCTOR REPORTED THAT THE PATIENT WAS BROUGHT INTO THE ER BY FIRST RESPONDERS SHORTLY AFTER A REFILL APPOINTMENT FOR INTRATHECAL FENTANYL. IT WAS REPORTED THAT THE PATIENT WAS ADMINISTERED NARCAN PRIOR TO REGAINING CONSCIOUSNESS. TECHNICAL SOLUTIONS INFORMED THE PHYSICIAN THAT THESE SYMPTOMS WERE ALIGNED WITH A POCKET FILL DUE TO THE SUDDEN ONSET OF SYMPTOMS. THEY ASKED TECHNICAL SOLUTIONS FOR NEXT STEPS AND TECHNICAL SOLUTIONS EXPLAINED HOW TO DRAIN THE PUMP TO SUSPEND FURTHER THERAPY. TECHNICAL SOLUTIONS ASKED THE PHYSICIAN TO NOTE AND SHARE THE VOLUME OF MEDICATION REMOVED FROM THE PUMP. TECHNICAL SOLUTION THEN SENT THE PHYSICIAN AN EMAIL WITH THE REFILL PROCEDURE AND OTHER PERTINENT INFORMATION. TECHNICAL SOLUTIONS MENTIONED THAT THEY WOULD BE AVAILABLE VIA PHONE CALL AS NEEDED TO ASSIST ON THE DRAINING. LATER, AN AGENT COVERING THE ISSUE CONTACTED TEC

  Patient problems: Loss of consciousness

  MAUDE report 16946046 ↗
• MalfunctionMay 11, 2023Communication or Transmission Problem; Communication or Transmission Problem

  PHYSICIAN CONTACTED TECHNICAL SOLUTIONS TO REPORT A PUMP THAT WAS UNABLE TO COMMUNICATE WITH SEVERAL CLINICIAN PROGRAMMERS. PHYSICIAN STATED THAT THE PUMP IS VERY SUPERFICIAL ON THE PATIENT AND DID NOT APPEAR TO HAVE FLIPPED. THE PATIENT HAD NOT EXPERIENCED ANY RECENT MRI'S, FALLS/ACCIDENTS, OR OTHER EVENTS THAT THE PHYSICIAN THOUGHT COULD HAVE CAUSED THIS ISSUE. PHYSICIAN STATED THAT THE PATIENT HAD NOT REPORTED ANY SYMPTOMS. THE PATIENT DID NOT BRING THEIR PATIENT THERAPY CONTROLLER (PTC) TO THE APPOINTMENT, SO THE PHYSICIAN COULD NOT TEST WHETHER OR NOT THAT DEVICE WAS ABLE TO COMMUNICATE WITH THE PUMP. THE PHYSICIAN THEORIZED THAT THE PUMP BATTERY HAD DIED PREMATURELY BUT STATED THAT THE LAST INQUIRY SUMMARY REPORT SHOWED THE BATTERY TO BE "OK". THE PHYSICIAN HAD SCHEDULED THE PATIENT'S PUMP TO BE EXPLANTED. ON THE DAY OF THE SURGERY, THE PHYSICIAN'S STAFF ATTEMPTED TO CONNECT WITH THE PATIENT'S PUMP AGAIN USING A CLINICIAN PROGRAMMER. PHYSICIAN STATED THAT THEY WERE ABLE TO CONNECT TO THE DEVICE AS NORMAL. PHYSICIAN STATED THAT THEY INQUIRED, SET THE DAILY DOSE TO ZERO, RESET THE DAILY DOSE TO THE TRUE VALUE, AND REPEATED THIS PROCESS WITHOUT FAIL THREE TIMES. AT THIS POINT, T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16910671 ↗
• InjuryMay 8, 2023Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  REPORTER CONTACTED TECHNICAL SOLUTIONS TO INQUIRE ABOUT SENDING AN EXPLANTED PUMP BACK. REPORTER STATED THAT THE PUMP WAS EXPLANTED BY THE PHYSICIAN DUE TO AN UNDERINFUSION VOLUME DISCREPANCY NOTED BY A NURSE TWO MONTHS PRIOR. REPORTER STATED THAT 1.2 ML WERE EXPECTED AT THE REFILL AND 13 ML WERE ACTUALLY ASPIRATED. THE REPORTER DID NOT HAVE FURTHER INFORMATION ON PATIENT SYMPTOMS, MRIS, OR ACCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887179 ↗
• InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT TRACKING RECEIVED A TRACKING FORM IN THE MAIL THAT REPORTED A PUMP REPLACEMENT. THE REASON FOR REPLACEMENT WAS REPORTED TO BE THAT THE PUMP "FAILED". THE REPLACED PUMP WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854362 ↗
• InjuryApr 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A REVISION SURGERY. THE REASON FOR REVISION SURGERY WAS STATED TO BE THAT THE PATIENT'S PUMP WAS FLIPPING, RESULTING IN THE CATHETER BECOMING TANGLED. THE REVISED CATHETER PORTION WAS DISCARDED. ADDITIONAL FOLLOW-UP WITH THE LOCAL AGENT COVERING THE ISSUE CONFIRMED THAT THE PATIENT HAD EXPERIENCED A LACK OF PAIN RELIEF AS A RESULT OF THE PUMP FLIPPING. THE CAUSE OF THE FLIPPING WAS STATED TO HAVE BEEN UNKNOWN. THE AGENT REPORTED THAT A PLASTIC SURGEON WAS PRESENT AT THIS REVISION SURGERY AND USED MESH TO HELP PREVENT ANY FURTHER FLIPPING IN THE FUTURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16807269 ↗
• MalfunctionApr 20, 2023Communication or Transmission Problem; Communication or Transmission Problem

  REPORTER CONTACTED TECHNICAL SOLUTIONS TO REPORT THAT A PATIENT'S PUMP WAS UNABLE TO COMMUNICATE WITH THEIR CLINICIAN PROGRAMMER. THE REPORTER STATED THAT THE PROGRAMMER DID NOT EMIT ANY BEEPING AND DOES NOT RECOGNIZE THE PUMP WHEN HELD DIRECTLY OVER IT. THE REPORTER TRIED RESTARTING THE PROGRAMMER SEVERAL TIMES AND CHANGING THE BATTERIES, BUT BOTH OF THESE STEPS WERE UNSUCCESSFUL IN RESOLVING THE ISSUE. THE REPORTER STATED THAT THE PUMP IS VERY SUPERFICIAL ON THIS PATIENT, AND THEY COULD FEEL THE REFILL SEPTUM, CONFIRMING THAT THE PUMP WAS NOT FLIPPED. THE REPORTER'S PROGRAMMER WAS ABLE TO SUCCESSFULLY INQUIRE ABOUT SIX PATIENTS THE PREVIOUS DAY, AND THE PATIENT DID NOT HAVE A PATIENT THERAPY CONTROLLER TO TEST WHETHER THAT DEVICE WAS ABLE TO CONNECT WITH THE PUMP OR NOT. THE PATIENT REPORTED AN INCREASE IN PAIN OVER THE PREVIOUS FOUR TO FIVE DAYS. THE PATIENT ALSO REPORTED NAUSEA, BUT STATED THAT THIS COULD BE CONTRIBUTED TO THE NEW MEDICATION THAT THEY HAD STARTED RECENTLY. THE PATIENT HAD NO RECENT MRIS, BUT DID REPORTEDLY HAVE A FALL AROUND THREE DAYS PRIOR. TECHNICAL SOLUTIONS ADVISED THE REPORTER THAT THEY SHOULD ATTEMPT CONNECTING TO THE PUMP WITH A DIFFERENT PROGRAMMER. TH

  Patient problems: Inadequate Pain Relief; Nausea

  MAUDE report 16775968 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P080012. One submission often covers many models, so check the product and lot details in each record.

• Z-1996-2021 · May 26, 2021 · Terminated
  Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Mode
• Z-1124-2020 · Dec 24, 2019 · Open, Classified
  Prometra Programmable 20mL Pump. Catalog No. 91827 The device is an implantable infusion pump. GTIN-14 00810335020XXX (XXX = in-country language specific)
• Z-1121-2020 · Dec 24, 2019 · Open, Classified
  Prometra II 20mL Pump. Catalog No. 13827 The device is an implantable infusion pump. GTIN-14 00810335020228
• Z-1123-2020 · Dec 24, 2019 · Open, Classified
  US Clinical 20mL Programmable Pump. Catalog No. 01827 The device is an implantable infusion pump. GTIN-14 00810335020082
• Z-1120-2020 · Dec 24, 2019 · Open, Classified
  Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082
• Z-1125-2020 · Dec 24, 2019 · Open, Classified
  Prometra II Programmable 20mL Pump. Catalog No. 93827 The device is an implantable infusion pump. GTIN-14 00810335020YYY (YYY= in-country language specific)
• Z-1122-2020 · Dec 24, 2019 · Open, Classified
  Prometra II 40mL Pump. Catalog No. 16827 The device is an implantable infusion pump. GTIN-14 00810335020242
• Z-1716-2019 · Mar 21, 2019 · Terminated
  Prometra II Programmable Pump (Clinical), Cat. No. 01827 For intrathecal infusion.
• Z-1715-2019 · Mar 21, 2019 · Terminated
  Prometra II Programmable Pump, Cat. No. 13827 For intrathecal infusion.
• Z-1712-2019 · Mar 21, 2019 · Terminated
  Prometra Clinician Programmer (Touchscreen) Software version 2.00.29, Cat. No. 12828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
• Z-1714-2019 · Mar 21, 2019 · Terminated
  Prometra Programmable Pump, Cat. No. 11827 For intrathecal infusion.
• Z-1713-2019 · Mar 21, 2019 · Terminated
  Prometra Programmer (Grand Prime) Software version 2.00.29, Cat. No. 13828, used with Prometra and Prometra II Programmable Pumps. For intrathecal infusion.
• Z-2740-2017 · May 22, 2017 · Terminated
  PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction i