Palindrome 8888541123Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521135543), received between Oct 23, 2017 and Oct 23, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, DURING HEMODIALYSIS THE DEVICE¿S ARTERIAL LUER ADAPTER BECAME DETACHED FROM THE(BIONIC) EXTENSION LINES. THE LUER ADAPTER HAD TO BE RECONNECTED ON THE ARTERIAL LINE. IT WAS SUSPECTED THAT THE PATIENT WAS DISCONNECTING THE ARTERIAL LINES. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6968357 ↗