Alaris 30893-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 10885403460234), received between Jan 19, 2018 and Dec 17, 2020 — classified as 28 injuries, 124 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (145 reports).

1 FDA recall record name this device's identifier.

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 16, 2026.

Recalls naming this device

1. Apr 9, 2020Terminated

   The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.

   Z-1967-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 152 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PCEA ASV YELLOW MICROBORE LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT EPIDURAL TUBING (SYRINGE TUBING) WAS FOUND TO BE LEAKING JUST ABOVE THE LUER LOCK (WHERE THE SECOND PIECE IS THAT TWISTS AROUND). VERBATIM: HI XXX, I NEED TO ENTER A PRODUCT DEFECT COMPLAINT WITH YOU. I HAVE RECEIVED 4 MIDAS REPORTS REGARDING LEAKING EPIDURAL TUBING OVER THE PAST 3 WEEKS. INITIALLY I THOUGHT IT WAS A ONE OFF OCCURRENCE BUT THAT DOES NOT SEEM TO BE THE CASE AFTER THE LAST EVENTS THAT WERE ENTERED OVER THE PAST COUPLE OF DAYS (SEE EMAIL BELOW WITH DETAILS FROM PHARMACY) I HAVE THE PRODUCTS TO SEND BACK FOR REVIEW IN MY OFFICE. PRODUCT IS CAREFUSION ITEM 3089307 ¿ SOUNDS LIKE IS COMING FROM MULTIPLE LOTS, THE ONLY LOT INFO I HAVE BEEN PROVIDED ARE LOT #¿S (10) 19025228 AND (10) 18126639 HERE ARE THE OCCURRENCES: MIDAS EVENT DATE EVENT COMMENTS 20-5462 (B)(6) 2020 EPIDURAL TUBING (SYRINGE TUBING) WAS FOUND TO BE LEAKING JUST ABOVE THE LUER LOCK (WHERE THE SECOND PIECE IS THAT TWISTS AROUND). 20-5490 (B)(6) 2020 EPIDURAL PCA (SYRINGE) TUBING NOTED TO BE LEAKING WHEN BED WAS DISCOVERED TO BE WET. LEAKING VISIBLE FROM THE TUBING ATT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11032732 ↗
• MalfunctionDec 16, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 PCEA ASV YELLOW MICROBORE LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT EPIDURAL PCA (SYRINGE) TUBING NOTED TO BE LEAKING WHEN BED WAS DISCOVERED TO BE WET. VERBATIM: HI XXX, I NEED TO ENTER A PRODUCT DEFECT COMPLAINT WITH YOU. I HAVE RECEIVED 4 MIDAS REPORTS REGARDING LEAKING EPIDURAL TUBING OVER THE PAST 3 WEEKS. INITIALLY I THOUGHT IT WAS A ONE OFF OCCURRENCE BUT THAT DOES NOT SEEM TO BE THE CASE AFTER THE LAST EVENTS THAT WERE ENTERED OVER THE PAST COUPLE OF DAYS (SEE EMAIL BELOW WITH DETAILS FROM PHARMACY). I HAVE THE PRODUCTS TO SEND BACK FOR REVIEW IN MY OFFICE. PRODUCT IS CAREFUSION ITEM 3089307 ¿ SOUNDS LIKE IS COMING FROM MULTIPLE LOTS, THE ONLY LOT INFO I HAVE BEEN PROVIDED ARE LOT #¿S (10) 19025228 AND (10) 18126639. HERE ARE THE OCCURRENCES: MIDAS EVENT: EVENT DATE: EVENT COMMENTS: (B)(4), (B)(6) 2020, EPIDURAL TUBING (SYRINGE TUBING) WAS FOUND TO BE LEAKING JUST ABOVE THE LUER LOCK (WHERE THE SECOND PIECE IS THAT TWISTS AROUND). (B)(4), (B)(6) 2020, EPIDURAL PCA (SYRINGE) TUBING NOTED TO BE LEAKING WHEN BED WAS DISCOVERED TO BE WET. LEAKING VISIBLE FROM THE TUBING ATTACHED TO SYRINGE, NOT BIFUSE OR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11023774 ↗
• MalfunctionApr 14, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT IN THE BIRTHING CENTER, TUBING CRACKED AT THE HUB WHICH RESULTED IN A PAIN MEDICATION LEAKING BELOW THE CONNECTION SITE DURING PATIENT USE ON THREE SEPARATE OCCASIONS ON TWO SEPARATE PATIENTS CAUSING THE PATIENTS TO LOSE THEIR PAIN RELIEF. THIS EVENT DID NOT RESULT IN A SERIOUS INJURY, AND IT WAS REPORTED IT¿S UNKNOWN IF THIS EVENT CAUSED A DELAY OR CHANGE IN THE COURSE OF TREATMENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9960898 ↗
• MalfunctionApr 14, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT IN THE BIRTHING CENTER, TUBING CRACKED AT THE HUB WHICH RESULTED IN A PAIN MEDICATION LEAKING BELOW THE CONNECTION SITE DURING PATIENT USE ON THREE SEPARATE OCCASIONS ON TWO SEPARATE PATIENTS CAUSING THE PATIENTS TO LOSE THEIR PAIN RELIEF. THIS EVENT DID NOT RESULT IN A SERIOUS INJURY, AND IT WAS REPORTED IT¿S UNKNOWN IF THIS EVENT CAUSED A DELAY OR CHANGE IN THE COURSE OF TREATMENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9960897 ↗
• MalfunctionApr 14, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT IN THE BIRTHING CENTER, TUBING CRACKED AT THE HUB WHICH RESULTED IN A PAIN MEDICATION LEAKING BELOW THE CONNECTION SITE DURING PATIENT USE. THIS EVENT DID NOT RESULT IN A SERIOUS INJURY, AND IT WAS REPORTED IT¿S UNKNOWN IF THIS EVENT CAUSED A DELAY OR CHANGE IN THE COURSE OF TREATMENT.

  Patient problems: No Information

  MAUDE report 9960896 ↗
• MalfunctionMar 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT (2) SETS ARE BEING SENT IN FOR INVESTIGATION. THE ISSUE WAS UNSPECIFIED, AND THEREFORE; THERE HAS BEEN NO IMPACT TO PATIENT OR ADDITIONAL INFORMATION MADE AVAILABLE TO DATE.

  Patient problems: No Information

  MAUDE report 9849576 ↗
• MalfunctionMar 18, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT (2) SETS ARE BEING SENT IN FOR INVESTIGATION. THE ISSUE WAS UNSPECIFIED, AND THEREFORE; THERE HAS BEEN NO IMPACT TO PATIENT OR ADDITIONAL INFORMATION MADE AVAILABLE TO DATE.

  Patient problems: No Information

  MAUDE report 9849575 ↗
• MalfunctionMar 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE TUBING LEAKS FROM THE DISTAL END WHERE THE PORT IS CONNECTED. THIS IS A RECURRING PROBLEM ACROSS MULTIPLE LOTS. THE PROBLEM CANNOT BE DETECTED UNTIL THE LINE IS IN THE PATIENT AND IN USE. DISCUSSED WITH STAFF IN CENTRAL DISTRIBUTION FOR THIS FACILITY SYSTEM. THEY ARE SEEING THIS PROBLEM AT MULTIPLE FACILITIES AND IN MULTIPLE LOTS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED. MULTIPLE REPORTS ARE BEING SENT TO THE MANUFACTURER ABOUT THIS PROBLEM." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9844894 ↗
• MalfunctionMar 17, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE TUBING LEAKS FROM THE DISTAL END WHERE THE PORT IS CONNECTED. THIS IS A RECURRING PROBLEM ACROSS MULTIPLE LOTS. THE PROBLEM CANNOT BE DETECTED UNTIL THE LINE IS IN THE PATIENT AND IN USE. DISCUSSED WITH STAFF IN CENTRAL DISTRIBUTION FOR THIS FACILITY SYSTEM. THEY ARE SEEING THIS PROBLEM AT MULTIPLE FACILITIES AND IN MULTIPLE LOTS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED. MULTIPLE REPORTS ARE BEING SENT TO THE MANUFACTURER ABOUT THIS PROBLEM." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9842241 ↗
• MalfunctionMar 13, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FEMALE PATIENTS DURING LABOR WERE NOT RECEIVING ADEQUATE DOSING OF FENTANYL /BUPIVACAINE MEDICATIONS DUE TO EPIDURAL IV TUBING SET LEAKING AT THE ENGAGEMENT OF THE MALE LUER, RESULTING IN PATIENTS NOT RECEIVING ADEQUATE DOSING OF EPIDURAL MEDICATION. RN HAD TO REPLACE IV TUBING SETS AND GET PATIENTS' PAIN UNDER CONTROL.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9832505 ↗
• MalfunctionMar 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE TUBING LEAKS FROM THE DISTAL END WHERE THE PORT IS CONNECTED. THIS IS A RECURRING PROBLEM ACROSS MULTIPLE LOTS. THE PROBLEM CANNOT BE DETECTED UNTIL THE LINE IS IN THE PATIENT AND IN USE. DISCUSSED WITH STAFF IN CENTRAL DISTRIBUTION FOR THIS FACILITY SYSTEM. THEY ARE SEEING THIS PROBLEM AT MULTIPLE FACILITIES AND IN MULTIPLE LOTS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED. MULTIPLE REPORTS ARE BEING SENT TO THE MANUFACTURER ABOUT THIS PROBLEM." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2020 WAS PROVIDED. IT WAS REPORTED THAT THE MEDICATION INFUSING AT THE TIME WAS "EPIDURAL MEDICATIONS." THERE WAS NO PATIENT OR CLINICIAN HARM AS A RESULT OF THE EVENT. THE EVENT DID NOT CAUSE A DELAY THAT SIGNIFICANTLY IMPACTED PATIENT OUTCOMES. ALTHOUGH REQUESTED, NO PATIENT DETAILS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9809194 ↗
• MalfunctionMar 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE TUBING LEAKS FROM THE DISTAL END WHERE THE PORT IS CONNECTED. THIS IS A RECURRING PROBLEM ACROSS MULTIPLE LOTS. THE PROBLEM CANNOT BE DETECTED UNTIL THE LINE IS IN THE PATIENT AND M USE. DISCUSSED WITH STAFF M CENTRAL DISTRIBUTION FOR THIS FACILITY SYSTEM. THEY ARE SEEING THIS PROBLEM AT MULTIPLE FACILITIES AND M MULTIPLE LOTS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED. MULTIPLE REPORTS ARE BEING SENT TO THE MANUFACTURER ABOUT THIS PROBLEM." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED. IT WAS REPORTED THAT THERE WAS NO HARM CAUSED TO THE CLINICIAN AS A RESULT OF THIS EVENT. ALTHOUGH REQUESTED, NO PATIENT DETAILS PROVIDED.

  Patient problems: No Information

  MAUDE report 9809113 ↗
• MalfunctionMar 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "NURSING NOTED BED WAS WET AND IDENTIFIED TUBING WAS LEAKING FROM DISTAL END WHERE PORT IS CONNECTED. NO OTHER CONNECTION ISSUES. CONCERN WITH PRODUCT LEAKING. DISCUSSED WITH STAFF IN CENTRAL DISTRIBUTION FOR THIS FACILITY SYSTEM. THEY ARE SEEING THIS PROBLEM AT MULTIPLE FACILITIES AND IN MULTIPLE LOTS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED. MULTIPLE REPORTS ARE BEING SENT TO THE MANUFACTURER ABOUT THIS PROBLEM." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2020 WAS PROVIDED. IT WAS REPORTED THAT THE MEDICATION INFUSING AT THE TIME WAS "EPIDURAL MEDICATIONS." THERE WAS NO PATIENT OR CLINICIAN HARM AS A RESULT OF THE EVENT. THE EVENT DID NOT CAUSE A DELAY THAT SIGNIFICANTLY IMPACTED PATIENT OUTCOMES. ALTHOUGH REQUESTED, NO PATIENT DETAILS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9808765 ↗
• MalfunctionMar 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE TUBING LEAKS FROM THE DISTAL END WHERE THE PORT IS CONNECTED. THIS IS A RECURRING PROBLEM ACROSS MULTIPLE LOTS. THE PROBLEM CANNOT BE DETECTED UNTIL THE LINE IS M THE PATIENT AND IN USE. DISCUSSED WITH STAFF IN CENTRAL DISTRIBUTION FOR THIS FACILITY SYSTEM. THEY ARE SEEING THIS PROBLEM AT MULTIPLE FACILITIES AND M MULTIPLE LOTS. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED. MULTIPLE REPORTS ARE BEING SENT TO THE MANUFACTURER ABOUT THIS PROBLEM". AN INCOMPLETE DATE OF EVENT OF XX-SEP-2019 WAS PROVIDED. IT WAS REPORTED THAT THERE WAS NO CLINICIAN HARM CAUSED BY THE EVENT. THE EVENT DID NOT CAUSE A DELAY THAT SIGNIFICANTLY IMPACTED THE PATIENT OUTCOME. ALTHOUGH REQUESTED, NO PATIENT ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9808743 ↗
• MalfunctionJan 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PCEA ADMINISTRATION TUBING WAS LEAKING NEAR THE CONNECTION TO THE LINE IN THE PATIENT. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9611717 ↗
• MalfunctionJan 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING PCEA TUBING. THE NURSE WAS CONCERNED ABOUT PATIENT SAFETY AS THE TUBING FOR THE EPIDURAL WAS LEAKING. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED. THIS FILE IS FOR (B)(6).

  Patient problems: No Information

  MAUDE report 9571901 ↗
• MalfunctionJan 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LEAKING PCEA TUBING. THE NURSE WAS CONCERNED ABOUT PATIENT SAFETY AS THE TUBING FOR THE EPIDURAL WAS LEAKING. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED. THIS FILE IS FOR ENCINITAS.

  Patient problems: No Information

  MAUDE report 9571655 ↗
• MalfunctionDec 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PCEA TUBING WAS LEAKING NEAR THE CONNECTION TO THE LINE IN THE PATIENT. THE CONNECTION WAS REPORTED TIGHT AND THE MEDICATION DRIPPED OUT OF THE TUBING ONTO THE PATIENT'S PILLOW. ALTHOUGH REQUESTED, THERE HAS BEEN NO IMPACT TO PATIENT RESPONSE OR ADDITIONAL EVENT INFORMATION MADE AVAILABLE TO DATE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9513224 ↗
• MalfunctionDec 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE EPIDURAL IV TUBING SET LEAKING AT THE ENGAGEMENT OF THE MALE LUER, RESULTING IN THE PATIENTS NOT RECEIVING ADEQUATE DOSAGE OF FENTANYL /BUPIVACAINE DURING LABOR. THE NURSE REPLACED THE IV TUBING SETS AND GOT THE PATIENTS' PAIN UNDER CONTROL.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9490320 ↗
• MalfunctionDec 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE EPIDURAL TUBING WAS LEAKING FROM THE PURPLE PORT END ON MULTIPLE SETS OF TUBING. FOUR WERE FOUND TO BE FAULTY. THE DOCTOR WAS UPSET BECAUSE THIS POSES AN INFECTION RISK FOR PATIENT NOT HAVING A CLOSED SYSTEM, WHICH CAN ENTER THE EPIDURAL SPACE." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 9481135 ↗
• MalfunctionDec 4, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SET LEAKED AT THE PORT, PATIENT SIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9413250 ↗
• MalfunctionDec 4, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE EPIDURAL TUBING LEAKED WHICH CAUSES DELAY OF TREATMENT. ALTHOUGH REQUESTED, THERE HAS BEEN NO FURTHER PATIENT OR EVENT INFORMATION MADE AVAILABLE TO DATE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9412461 ↗
• MalfunctionDec 3, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE EPIDURAL TUBING LEAKED WHICH CAUSES DELAY OF TREATMENT. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405126 ↗
• MalfunctionDec 3, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE EPIDURAL TUBING LEAKED, WHICH CAUSES A DELAY OF TREATMENT. IT WAS CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT HARM OR IMPACT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9405122 ↗
• MalfunctionDec 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT; EPIDURAL IV TUBING SETS WERE LEAKING AT THE ENGAGEMENT OF THE MALE LUER, RESULTING IN FEMALE LABOR PATIENTS NOT RECEIVING ADEQUATE DOSING OF FENTANYL /BUPIVACAINE. THE NURSE REPLACED THE IV TUBING SETS, ENABLING THE PATIENTS TO RECEIVE THE CORRECT DOSAGE OF MEDICATION AND GOT PAIN UNDER CONTROL. IT WAS FURTHER CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT HARM OR IMPACT AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9403548 ↗