Prometra Programmable Pump 16827Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00810335020242), received between Mar 10, 2020 and Apr 6, 2023 — classified as 29 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT TRACKING RECEIVED A TRACKING FORM IN THE MAIL REPORTING A REVISION SURGERY. A CATHETER WAS REPLACED AND DISCARDED WHILE THE PATIENT'S PUMP WAS MOVED FROM THEIR ABDOMEN TO THEIR RIGHT BUTTOCKS. FOLLOW-UP COMMUNICATION WAS SENT TO THE REPRESENTATIVE REQUESTING THE REASON FOR PUMP RELOCATION. REPRESENTATIVE REPORTED THAT THE REVISION OCCURRED DUE TO "PATIENT COMFORT," CONFIRMED TO BE RELATED TO UNANTICIPATED DISCOMFORT REPORTED BY THE PATIENT RATHER THAN INAPPROPRIATE INITIAL PLACEMENT OF THE PUMP.

  Patient problems: Discomfort

  MAUDE report 16693455 ↗
• InjuryFeb 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT TRACKING RECEIVED A TRACKING FORM THROUGH EMAIL REPORTING A CATHETER REVISION. THE REASON FOR REVISION WAS DUE TO PUMP FLIPPING. ADDITIONAL COMMUNICATION WITH THE REPORTER OF THE ISSUE CONFIRMED THAT THE PATIENT'S PUMP WAS INITIALLY SUTURED DOWN, BUT THEN BEGAN FLIPPING. THE REPORTER STATED THAT THE ISSUE WAS DIAGNOSED WHEN THE CLINIC WAS TRYING TO PERFORM A REFILL AND THE PROGRAMMER WASN'T READING THE PUMP. THE REPORTER STATED THAT THE DEVICE HAD TO BE MANUALLY FLIPPED TO PERFORM THE REFILL. THE REPORTER STATED THAT THE PUMP IS NOW SUTURED DOWN TO THE MUSCLE AS OPPOSED TO THE FAT TO ENSURE THAT THE PUMP FLIPPING WOULD NOT HAPPEN AGAIN. NO DEVICES WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385631 ↗
• MalfunctionFeb 16, 2023Pumping Stopped; Pumping Stopped

  REPORTER CONTACTED TECHNICAL SOLUTIONS TO REPORT ERROR CODES 100, 103, AND 116 THAT SHOWED WHEN THEY ATTEMPTED TO INQUIRE A PATIENT'S PUMP. THEY REPORTED THAT THEY HAD EMPTIED AND REFILLED THE PUMP PRIOR TO INQUIRING IT, AND THE ERROR CODES APPEARED WHEN THEY FIRST ATTEMPTED INQUIRY. REPORTER STATED THAT THE PATIENT WAS HOSPITALIZED DUE TO PNEUMONIA FOR SEVERAL WEEKS PRIOR TO THIS EVENT. THE PATIENT REPORTED INCREASED SPASMS THAT STARTED TWO WEEKS AGO, AROUND THE TIME THEY HAD A CT SCAN. THE PATIENT ALSO REPORTED SPASMS IN THEIR STOMACH, WHICH THEY HAD NOT EXPERIENCED BEFORE. REPORTER STATED THAT THE PATIENT HAS NOT UNDERGONE ANY MRIS RECENTLY AND THAT THEIR ORAL DOSE OF NEURONTIN HAD RECENTLY BEEN DECREASED. TECHNICAL SOLUTIONS ASKED THE REPORTER TO PROGRAM AN "EMERGENCY PUMP STOP" FOLLOWED BY A DEMAND BOLUS OF 0 MG FOR 1 MINUTE. REPORTER WAS ABLE TO PROGRAM THE PUMP STOP, BUT THE PROGRAMMER DISPLAYED "PUMP COMMUNICATION FAILED" EACH TIME THEY TRIED TO ENTER THE BOLUS MENU. REPORTER ATTEMPTED THIS THREE TIMES, EACH WITH THE SAME RESULT. TECHNICAL SOLUTIONS PROVIDED THE REPORTER WITH CONTACT INFORMATION FOR THE DIRECTOR OF CLINICAL ENGINEERING SO THE REPORTER COULD COORDINATE A TIM

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

  MAUDE report 16385630 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FLOWONIX INITIALLY RECEIVED A REPORT ABOUT A PATIENT ALLEGING UNRELIEVED PAIN AND A POTENTIAL DEVICE MALFUNCTION. THE AGENT COVERING THE ISSUE REPORTED THAT THERE WERE NO VOLUME DISCREPANCIES. THE AGENT REPORTED THAT THE OFFICE INCREASED THE DAILY DOSE BY 1-2% EACH VISIT, AND THE PATIENT WAS THEN SCHEDULED TO HAVE A DYE STUDY PERFORMED. A DYE STUDY WAS LATER PERFORMED, WHICH SHOWED THAT DRUG WAS NOT FLOWING FROM THE CATHETER. AGENT REPORTED THAT THE PATIENT REQUESTED THAT THE PUMP BE EXPLANTED AND KEPT IN THEIR POSSESSION. THE CATHETER ISSUE WAS CAPTURED IN MDR 3010079947-2021-00069. VOLUNTARY MW5114474 WAS LATER RECEIVED FROM FDA. REPORTER STATED THAT THEIR SPOUSE HAD PUMP IMPLANTED AFTER BEING DIAGNOSED WITH PANCREATIC CANCER. DOCTORS IMPLANTED A "PROMETRA FLOWONIX PUMP" WHICH "SEEMED TO STABILIZE [THE PATIENT'S] PAIN"; HOWEVER SHORTLY AFTERWARDS, REPORTER ALLEGED NEEDING TO RETURN TO THE HOSPITAL WITH THE PATIENT "TWICE WEEKLY/EVERY THREE DAYS." THE PATIENT WOULD HAVE THEIR MEDS INCREASED, ALTHOUGH "SEVERAL ER VISITS MORE HOSPITAL STAYS" WERE REPORTED. A NUCLEAR TEST WAS REPORTEDLY PERFORMED TO "CHECK THE DEVICE" AFTER "3 DAYS OF X-RAYS SHOWED THE DEVICE WAS NOT WORKING". PATIEN

  Patient problems: Inadequate Pain Relief; Seroma

  MAUDE report 16351807 ↗
• InjuryJul 27, 2022Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT A PUMP REPLACEMENT FOR A PATIENT WHO HAD MULTIPLE VOLUME DISCREPANCIES. CS STATED THAT THE PATIENT WAS EXPERIENCING A LACK OF PAIN RELIEF. CS ALSO REPORTED THAT A DYE STUDY WAS PERFORMED THAT SHOWED THAT THE CATHETER WAS WORKING FINE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15115651 ↗
• MalfunctionJun 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CS STATED THAT EVERY TIME THE PATIENT PRESSES THE RX BUTTON AND HOLDS IT OVER THE PUMP, THE PATIENT THERAPY CONTROLLER (PTC) READS UNABLE TO FIND THE PUMP. CS REPORTED THAT THE PATIENT WAS INITIALLY NOT ABLE TO DELIVER BOLUSES. CS LATER FOLLOWED UP AND CONFIRMED THAT THE PATIENT'S PUMP WAS FLIPPED AND THEIR PHYSICIAN'S ASSISTANT FLIPPED IT BACK AND WAS ABLE TO DELIVER A BOLUS SUCCESSFULLY. CS REPORTED THAT THE PATIENT'S PUMP WAS SUTURED DOWN AT IMPLANT AND THAT THE PHYSICIAN DID NOT KNOW THE REASON FOR THE PUMP FLIPPING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14750769 ↗
• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN CONTACTED TECHNICAL SOLUTIONS ABOUT A PATIENT THAT PRESENTED TO THE EMERGENCY ROOM WITH SIGNS OF AN OVERDOSE: PINPOINT EYES, LOSS OF COORDINATION, AND MORE. TECHNICAL SOLUTIONS WALKED THE PHYSICIAN THROUGH A DRAIN OF THE RESERVOIR WHICH WOULD EFFECTIVELY TURN THE PUMP OFF. TECHNICAL SOLUTIONS REFERRED THE EMERGENCY ROOM PHYSICIAN TO THE PATIENT'S MANAGING PHYSICIAN. REPORTING PHYSICIAN STATED THAT THE PATIENT IS STILL BEING EVALUATED, BUT THEY BELIEVED THAT A CHANGE IN THE PATIENT'S DOSING REGIMEN IS WHAT LED TO THE PATIENT SYMPTOMS. ADDITIONAL COMMUNICATION WITH NURSE FROM THE MANAGING PHYSICIAN'S OFFICE CONFIRMED THAT THE PATIENT'S PUMP WAS EMPTIED AND FILLED WITH SALINE. THE CAUSE OF THE PATIENT'S OVERDOSE SYMPTOMS IS UNKNOWN. THE PATIENT'S DOSAGE HAD NOT BEEN RECENTLY CHANGED AS THE LAST CHANGE WAS A YEAR AGO. THE PATIENT WAS SCHEDULED FOR A PUMP REFILL TWO AND A HALF WEEKS AGO, BUT CANCELLED THEIR APPOINTMENT. PHYSICIAN'S ASSISTANT FROM HOSPITAL ALSO COMMUNICATED TO THE OFFICE THAT PATIENT WISHES TO HAVE PUMP REMOVED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Movement Disorder; Unspecified Eye / Vision Problem

  MAUDE report 14523005 ↗
• InjuryMay 18, 2022Communication or Transmission Problem; Communication or Transmission Problem

  CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT A PATIENT'S PUMP THAT WAS NOT COMMUNICATING WITH THE CLINICIAN PROGRAMMER. THERE WERE NO VOLUME DISCREPANCIES ALLEGED AND NO PATIENT SYMPTOMS ALLEGED EITHER. THE PHYSICIAN WAS ABLE TO ACCESS THE PUMP AND REFILL THE PUMP, BUT CANNOT CHANGE ANY OF THE PROGRAMMING PARAMETERS. DIRECTOR OF CLINICAL ENGINEERING ATTEMPTED SEVERAL TIMES WITH DIFFERENT PROGRAMMERS TO COMMUNICATE WITH THE PUMP, BUT WAS UNSUCCESSFUL. THE PUMP WAS LATER EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428713 ↗
• InjuryMay 12, 2022Use of Device Problem; Use of Device Problem

  OFFICE MANAGER OF PHYSICIAN'S OFFICE CONTACTED TECHNICAL SOLUTIONS TO REPORT A PATIENT'S ADVERSE REACTIONS AFTER A REFILL PROCEDURE. DURING THE CALL, TECHNICAL SOLUTIONS DETERMINED THAT DURING THE REFILL, ONLY 9ML OF THE 20ML WAS ABLE TO BE PULLED BACK WHEN THE VOLUME CHECK WAS PERFORMED. BASED ON THIS INFORMATION, THIS ISSUE IS BELIEVED TO A POCKET FILL RATHER THAN A PUMP MALFUNCTION. NARCAN WAS ADMINISTERED TO THE PATIENT AND THEY WERE TAKEN TO THE HOSPITAL. OFFICE MANAGER REPORTED THAT THE PATIENT IS DOING FINE NOW.

  Patient problems: Insufficient Information

  MAUDE report 14380172 ↗
• InjuryMar 9, 2022Pumping Stopped; Pumping Stopped

  A PATIENT CONTACTED TECHNICAL SOLUTIONS TO REPORT THAT THEIR PATIENT THERAPY CONTROLLER WAS SHOWING ERROR CODE 15. THE PATIENT ALLEGED THAT THEY WERE BEGINNING TO EXPERIENCE WITHDRAWAL SYMPTOMS. THE PATIENT VISITED THEIR PHYSICIAN THE NEXT MORNING IN ORDER TO HAVE THEIR PUMP INQUIRED. UPON INQUIRY, A REPRESENTATIVE FROM THE PHYSICIAN'S OFFICE REPORTED THAT THE PATIENT'S PUMP WAS SHOWING ERROR CODES 100 AND 104. THE PHYSICIAN DECIDED TO IMMEDIATELY REPLACE THE PUMP.

  Patient problems: Discomfort

  MAUDE report 13715432 ↗
• InjuryOct 22, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  SALES REPRESENTATIVE EMAILED TECHNICAL SUPPORT TO REPORT A VOLUME DISCREPANCY. THEY REPORTED THAT A PHYSICIAN WENT TO FILL THE PUMP AND FOUND 38ML OF VOLUME WHEN IT SHOULD HAVE BEEN MUCH LESS (EXPECTED AMOUNT UNKNOWN). REPRESENTATIVE REPORTED THAT A DYE STUDY WAS PERFORMED AFTER THE PATIENT REPORTED LITTLE-TO-NO PAIN RELIEF. THE DYE STUDY FOUND THE CATHETER TO BE PATENT. REPRESENTATIVE REPORTED NO RECENT FALLS, INJURIES OR MRIS. ANOTHER CAP STUDY WAS PERFORMED AT A LATER DATE, AND IT WAS OBSERVED THAT THE CAP CHAMBER ALONG WITH THE PUMP STEM AND CATHETER ALREADY CONTAINED A RADIOPAQUE SOLUTION. ALSO NOTED WAS THE POSITION OF THE BALL VALVE WITHIN THE FAV HAVING AN "AIR GAP" ON EACH SIDE OF THE BALL VALVE. CAP ASPIRATION OF CSF WAS SUCCESSFUL AND WITHOUT FLOW RESISTANCE. DYE WAS EASILY INFUSED VIA THE CAP WITH DYE ACCUMULATION OBSERVED AT THE BOTTOM OF T9 WITH NO EVIDENCE OF DYE LEAKAGE IN THE PUMP POCKET OR ALONG THE CATHETER PATHWAY. DYE WAS AGAIN NOTED IN THE CAP CHAMBER, PUMP STEM, CATHETER, AND TUBING THAT CONNECTED THE DYE SYRINGE TO THE CAP NEEDLE. THE POSITION OF THE BALL VALVE WITHIN THE FAV HAD REPORTEDLY CHANGED TO THE "NORMAL" POSITION WITH A SINGLE "AIR GAP" ONLY ON THE

  Patient problems: Inadequate Pain Relief

  MAUDE report 12682715 ↗
• InjuryOct 12, 2021Migration; Migration

  AGENT REPORTED A PUMP POCKET REVISION AND SUBSEQUENT CATHETER REVISION. AGENT CONFIRMED THAT THE REASON FOR THE PUMP POCKET REVISION AND CATHETER REVISION WAS THAT THE PATIENT'S PUMP MIGRATED. IT WAS CONFIRMED THAT THE PUMP WAS INITIALLY SUTURED DOWN, BUT THE SUTURES BROKE WHICH RESULTED IN THE MIGRATION. THE PUMP MIGRATION RESULTED IN SKIN BREAKDOWN AND DISCOMFORT FOR THE PATIENT. IT WAS CONFIRMED THAT THE REMOVED SEGMENT OF CATHETER WOULD NOT BE RETURNED, AND THE ORIGINAL PUMP WAS RELOCATED TO THE NEW PUMP POCKET.

  Patient problems: Discomfort; Skin Erosion

  MAUDE report 12617374 ↗
• InjuryOct 8, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  SALES REPRESENTATIVE CONTACTED TECHNICAL SOLUTIONS TO REPORT A PUMP REPLACEMENT DUE TO MULTIPLE UNDERINFUSION VOLUME DISCREPANCIES. AT THE FIRST VOLUME DISCREPANCY, THE EXPECTED VOLUME WAS 22.7ML AND THE ACTUAL ASPIRATED VOLUME WAS 38.5ML. AROUND A WEEK LATER, ANOTHER UNDERINFUSION VOLUME DISCREPANCY WAS OBSERVED WITH THE EXPECTED VOLUME BEING 31.2ML AND THE ACTUAL ASPIRATED VOLUME BEING 38.5ML. APPROXIMATELY TWO WEEKS AFTER THAT DISCREPANCY, ANOTHER VOLUME DISCREPANCY WAS ALLEGED WITH THE EXPECTED VOLUME BEING 28ML AND THE ACTUAL ASPIRATED VOLUME BEING 39.7ML. A STETHOSCOPE TEST WAS PERFORMED, AND THE PHYSICIAN COULD HEAR THE VALVES CLICKING. THE PATIENT REPORTED AN INCREASE IN PAIN. THE NEXT DAY, A CATHETER DYE STUDY WAS PERFORMED. THE PATIENT WAS PUT INTO RIGHT LATERAL POSITION AND THE CATHETER WAS FOUND TO BE PATENT. THE PUMP WAS LATER REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12598314 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AGENT STATED THAT A PUMP WAS REPLACED DUE TO INFECTION. THE PUMP WAS DISCARDED.

  Patient problems: Unspecified Infection

  MAUDE report 12360555 ↗
• InjuryAug 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AGENT REPORTED A POCKET REVISION DUE TO THE PUMP ROTATING IN THE POCKET. THIS ROTATION CAUSED THE CATHETER TO WRAP AND KINK, CAUSING THE FLOW OF MEDICATION TO BE OBSTRUCTED. THE PUMP WAS FOUND TO BE OPERATING NORMALLY. THE PUMP WAS SUTURED DOWN DURING THE INITIAL IMPLANT. DURING THE REVISION, ADDITIONAL SUTURES WERE ADDED TO SECURE THE PUMP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12287232 ↗
• InjuryAug 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SALES REPRESENTATIVE CONTACTED TECHNICAL SOLUTIONS TO REPORT AN INCIDENCE OF PUMP FLIPPING. IT WAS REPORTED THAT THE PATIENT'S PUMP HAD BEEN FLIPPING AND HAD SHEARED THE CATHETER. AS A RESULT, THE PATIENT REPORTED A LACK OF PAIN RELIEF AND IT WAS REPORTED THAT CSF AND MEDICATION WERE FILLING IN THE PUMP POCKET, WHICH CAUSED THE PATIENT TO HAVE A SPINAL HEADACHE. THE CATHETER WAS REVISED AND THE PUMP POCKET WAS MOVED SLIGHTLY AND THE PUMP WAS THOROUGHLY SUTURED BACK DOWN.

  Patient problems: Cerebrospinal Fluid Leakage; Headache; Inadequate Pain Relief

  MAUDE report 12263677 ↗
• InjuryJul 29, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT PATIENT EFFECTS FOLLOWING AN MRI. AT THE MRI APPOINTMENT WHEN THE PUMP WAS EMPTIED A 2.8ML OVERINFUSION VOLUME DISCREPANCY WAS OBSERVED. THE PUMP WAS EMPTIED AND TURNED OFF BEFORE THE MRI. THE PATIENT WAS SCANNED FOR APPROXIMATELY AN HOUR, AND FELT LIGHTHEADED WHEN EXITING THE SCAN. CS PERFORMED THE POST-MRI PROCEDURE AND PULLS A 30 SECOND VACUUM USING A 5CC SYRINGE TO ENSURE THE VALVES ARE CLOSED. THE PUMP WAS THEN REFILLED AND RESTARTED. CS REPORTED THAT THE PATIENT WAS BROUGHT TO THE HOSPITAL A FEW HOURS LATER DUE TO SLURRED SPEECH AND DIFFICULTY WALKING. IT WAS CONFIRMED THAT THE PATIENT DID NOT TAKE ANY ORAL MEDICATION BEFORE OR AFTER THE MRI. THE PATIENT WAS ADMINISTERED NARCAN WHILE IN THE EMERGENCY ROOM. A VOLUME CHECK WAS DONE WHILE THE PATIENT WAS IN THE HOSPITAL AND THERE WAS NO DISCREPANCY OBSERVED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Dizziness; Movement Disorder; Speech Disorder

  MAUDE report 12247807 ↗
• InjuryJul 6, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  SALES REPRESENTATIVE CONTACTED TECHNICAL SOLUTIONS TO REPORT A POCKET REVISION AS A RESULT OF THE PATIENT WANTING THE PUMP MOVED FROM THE BACK TO THE FRONT DUE TO POOR INITIAL PLACEMENT AND IRRITATION. REPRESENTATIVE STATED THAT THERE WAS "LESS-THAN-IDEAL" PAIN CONTROL, BUT THERE WAS NO EROSION THROUGH THE SKIN AT THE ORIGINAL PLACEMENT. THE PATIENT'S CATHETER WAS REVISED DUE TO THE LACK OF PAIN RELIEF, WITH THE CATHETER TIP BEING LOWERED FROM T6 TO T9. AFTER THE REVISION, THE PATIENT HAS HAD NO NEW ISSUES. MFR 3010079947-2021-00195 WAS OPENED TO ADDRESS CATHETER REVISION.

  Patient problems: Discomfort; Inadequate Pain Relief

  MAUDE report 12124882 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOME INFUSION NURSE CONTACTED TECHNICAL SOLUTIONS TO REPORT A PUMP REPLACEMENT AND POCKET REVISION DUE TO THE PATIENT'S DISCOMFORT. THEY REPORTED THAT THE PATIENT COMPLAINED THEIR 40 ML PUMP WAS TOO LARGE, STICKING TOO FAR OUT, AND WAS GIVING THEM DISCOMFORT. THEY REPORTED THAT THEY BELIEVE THE PUMP WAS REPLACED WITH A 20 ML MODEL AND THE POCKET WAS MOVED. NURSE WAS UNSURE IF THE PUMP WAS DISCARDED.

  Patient problems: Discomfort

  MAUDE report 12107146 ↗
• InjuryJun 21, 2021Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  SALES REPRESENTATIVE CONTACTED TECHNICAL SOLUTIONS TO REPORT A PUMP EXPLANT AND REPLACEMENT WITH MEDTRONIC PUMP DUE TO UNDERINFUSION VOLUME DISCREPANCY. THE EXPECTED VOLUME WAS 24ML AND THE ACTUAL ASPIRATED VOLUME WAS 32ML. THE PATIENT COMPLAINED OF INCREASED PAIN SEVERAL TIMES. A CATHETER DYE STUDY WAS PERFORMED IN RESPONSE TO THE ALLEGATION OF INCREASED PAIN BUT SHOWED A PATENT CATHETER. WEEKS LATER, THE PATIENT AGAIN COMPLAINED OF INCREASE PAIN AND ALSO REPORTED THAT THEY WERE FEELING ELECTRICAL SHOCKS THAT THEY FELT WERE RELATED TO THEIR PUMP. ANOTHER DYE STUDY WAS PERFORMED AND AGAIN SHOWED A PATENT CATHETER. THE PATIENT CONTACTED THEIR PHYSICIAN TO STATE THAT THEY WERE GOING THROUGH WITHDRAWAL, AND WAS LATER BROUGHT TO THE HOSPITAL. THE PATIENT LATER HAD THEIR PUMP EXPLANTED AND REPLACED.

  Patient problems: Discomfort; Inadequate Pain Relief

  MAUDE report 12037511 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AGENT CONTACTED TECHNICAL SOLUTIONS TO REPORT A PATIENT THAT WAS SENT TO THE EMERGENCY ROOM DUE TO HYPOXIA SYMPTOMS. AGENT REPORTED THAT THE PATIENT HAD RECENTLY RECEIVED A REPLACEMENT PUMP. AGENT ALSO REPORTED THAT THE PATIENT HAD REPORTED TO THEIR MANAGING PHYSICIAN THAT THEY WERE "FEELING A BIT SEDATED". AGENT REPORTED THAT THE PATIENT WAS SUPPOSED TO HAVE AN APPOINTMENT WITH THEIR PHYSICIAN BUT WAS BROUGHT TO THE HOSPITAL INSTEAD DUE TO THE HYPOXIA SYMPTOMS. THIS PATIENT HAS NOT HAD ANY RECENT MRIS OR INJURIES. AGENT REPORTED THAT THE PATIENT ALSO TAKES ORAL PAIN MEDICATION, BUT DOES NOT KNOW THE SPECIFIC KIND. AGENT ALSO REPORTED THAT THE ER PHYSICIAN ORDERED THAT THE PUMP RUN AT ITS MINIMUM FLOW RATE, WHICH THEY WERE ABLE TO PROGRAM.

  Patient problems: Hypoxia; Nausea; Vomiting

  MAUDE report 11863300 ↗
• InjuryMay 11, 2021Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion; Excess Flow or Over-Infusion; Insufficient Flow or Under Infusion

  SALES REPRESENTATIVE CONTACTED TECHNICAL SOLUTIONS VIA EMAIL TO REPORT A PROMETRA II 40 ML PUMP WITH AN UNDERINFUSION VOLUME DISCREPANCY. THE EXPECTED VOLUME WAS 8ML AND THE ACTUAL ASPIRATED VOLUME WAS 30ML. THE PHYSICIAN PERFORMED A CATHETER DYE STUDY IN WHICH THE CATHETER WAS DETERMINED TO BE PATENT. LATER COMMUNICATION FROM THE PHYSICIAN CONFIRMED THAT THE PATIENT WAS LETHARGIC AND WAS HOSPITALIZED. DAYS LATER, AN OVERINFUSION VOLUME DISCREPANCY WAS OBSERVED. THE EXPECTED VOLUME WAS 36ML AND THE ACTUAL ASPIRATED VOLUME WAS 27ML. THE PUMP WAS EMPTIED AND TURNED OFF AND LATER EXPLANTED.

  Patient problems: Lethargy

  MAUDE report 11806342 ↗
• InjuryApr 27, 2021No Flow; No Flow

  CLINICAL SPECIALIST (CS) CONTACTED TECHNICAL SOLUTIONS TO REPORT A PATIENT THAT WAS BROUGHT INTO THE HOSPITAL WITH BACLOFEN WITHDRAWAL SYMPTOMS. CS REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN MUSCLE STIFFNESS AND EXTREME SWEATING. CS ALSO REPORTED THAT A VOLUME CHECK WAS NOT DONE ON THE PUMP BECAUSE THE PHYSICIAN DID NOT WANT TO REMOVE ANY MEDICATION DUE TO THE LOCATION NOT HAVING ANY BACLOFEN READILY AVAILABLE TO REFILL THE PUMP. ADDITIONALLY, THE PATIENT WAS FOUND TO HAVE A BLOOD INFECTION. CS STATED THAT THEY COULD NOT CONFIRM WHETHER THE CAUSE OF THE BLOOD INFECTION WAS KNOWN, BUT THAT THE INFECTION WAS NOT RELATED TO PUMP THERAPY. A DYE STUDY WAS PERFORMED IN WHICH THE CAP COULD NOT BE ASPIRATED. THE PATIENT'S PUMP WAS LATER EXPLANTED.

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

  MAUDE report 11731777 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AGENT STATED THAT THE PHYSICIAN HAD OPTED TO SWITCH THE PATIENT FROM A 20ML TO A 40ML TO DETERMINE IF THE PATIENT COULD 'TOLERATE' THE LARGER PUMP FOR THE BENEFITS OF THE LARGER RESERVOIR. THE PATIENT REPORTEDLY HAD A PIMPLE AT THE PUMP SITE THAT GOT INFECTED IN ADDITION TO 'TERRIBLE SKIN BREAKDOWN' ISSUES. AS A RESULT, THE PHYSICIAN OPTED TO SWITCH BACK TO THE 20ML PUMP. AGENT CONFIRMED THAT THE PHYSICIAN DID NOT ALLEGE ANY ISSUE WITH THE PUMP ITSELF. THE REPLACED PUMP WILL NOT BE RETURNED.

  Patient problems: Skin Erosion

  MAUDE report 11694335 ↗
• InjuryApr 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AGENT CONTACTED TECHNICAL SOLUTIONS TO REPORT A PATIENT CONTACTED THEM INDICATING THAT THEY HAVE HAD THEIR PUMP FLIP MULTIPLE TIMES TO THE POINT WHERE IT REQUIRED SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE PATIENT'S PUMP WAS REPLACED WITH A MEDTRONIC PUMP ON AN UNKNOWN DATE. THE PUMP WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667938 ↗

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 M
• 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-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-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-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-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-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-1716-2019 · Mar 21, 2019 · Terminated
  Prometra II Programmable Pump (Clinical), Cat. No. 01827 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-1715-2019 · Mar 21, 2019 · Terminated
  Prometra II Programmable Pump, Cat. No. 13827 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