Crono Super PIDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08050616612021), received between May 25, 2021 and Aug 8, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (1 report).

1 other recall cover devices cleared under the same FDA submission (K052217); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2024Infusion or Flow Problem; Infusion or Flow Problem

  WE WERE MADE AWARE BY OUR DISTRIBUTOR OF AN EVENT REPORTED ON MAUDE DATABASE (REPORT NUMBER MW5153640) OF WHICH WE HAD NOT BEEN MADE PREVIOUSLY AWARE. EVENT DESCRIPTION: "SPOKE WITH MEMBER'S NURSE, SHE DID INFUSION FOR DEFEROXAMINE, AND IT RAN OVER 8 HOURS JUST FINE PREVIOUS DAY. TODAY MORNING, SHE STARTED THE INFUSION, AND PUMP WAS INFUSING TOO FAST, IN ABOUT 45 MINUTES, ALMOST LESS THAN HALF OF THE MEDICATION WAS ADMINISTERED. SHE STOPPED THE INFUSION. SHE ASKED PHARMACY TO CONTACT HER FOR ASSISTANCE. PHARMACIST REACHED OUT, HOWEVER SHE WAS UNABLE TO REPROGRAM THE PUMP HERSELF, ARRANGED FOR REPLACEMENT PUMP TO BE SENT. MEMBER MISSED HALF OF INFUSION THE DAY OF THE OCCURRENCE OF PUMP FAILURE, HOWEVER NEW ONE WAS SENT FOR NEXT DAY DELIVERY, THEREFORE SHOULD NOT HAVE MISSED ANY FURTHER DOSES. NO ADVERSE EFFECTS REPORTED. PUMP WOULD BE RETURNED ONCE MEMBER RECEIVES THE RETURN BOX. AT THE TIME OF CALL, NO LOT NUMBER OR FURTHER PUMP INFO AVAILABLE. INDICATION: HEMOCHROMATOSIS DUE TO REPEATED RED BLOOD CELL TRANSFUSIONS. REPORTED TO (B)(6) BY: HEALTH PROFESSIONAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939035 ↗
• InjuryMay 25, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  WE WERE MADE AWARE BY OUR DISTRIBUTOR OF AN EVENT REPORTED ON MAUDE DATABASE (REPORT NUMBER MW5100144) OF WHICH WE HAD NOT BEEN MADE PREVIOUSLY AWARE. EVENT DESCRIPTION: "SPOKE WITH PATIENT REGARDING ISSUES WITH DEFERRAL AND CRONE PUMP, SHE ADVISED YESTERDAY SHE THOUGHT BATTERY WAS LOW SO SHE TOOK OUT BATTERIES AND PUT THEM BACK IN. SHE NOTICED DURING HER SCHEDULED INFUSION THAT IT STARTED BEEPING AND INFUSION WAS COMPLETED AFTER ONLY 30 MINUTES INSTEAD OF USUAL 8 HOURS. SHE REACHED OUT TO HER NURSE AND WAS ADVISED TO SEEK MEDICAL ATTENTION SINCE SHE REPORTED SIDE EFFECTS OF HEART PALPITATIONS. SHE CALLED ON-CALL MD FOR HEMATOLOGY AND THEY ADVISED SHE SHOULD BE OKAY. SHE WENT TO MD AND SOME BLOOD WORK AND HAD LOW HEMOGLOBIN. SCHEDULED TO RECEIVE A BLOOD TRANSFUSION FOR THIS TOMORROW. SHE SAID EARLIER THAT SHE DID HAVE THE HEART PALPATIONS, HEADACHE, NAUSEA AND STOMACH CRAMPS. SHE ADVISED SHE IS NO LONGER EXPERIENCING THESE SIDE EFFECTS. FOLLOWING UP WITH MD AND NURSING TOMORROW. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER."

  Patient problems: Abdominal Cramps; Anemia; Headache; Nausea

  MAUDE report 11876729 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K052217. One submission often covers many models, so check the product and lot details in each record.

• Z-0099-2015 · Oct 18, 2013 · Terminated
  CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"