TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
Received Oct 20, 2025 · Event occurred Sep 28, 2025
Report 2015691-2025-08628 · MDR key 23334271
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
68 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.
Description of Event or Problem
AS REPORTED, PRIOR TO CONNECTING THIS PRESSURE MONITORING SET TO THE PATIENT, THE PRESSURE TUBING BECAME DETACHED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.
Additional Manufacturer Narrative
ADDED: H2 (TYPE OF FOLLOW-UP). UPDATED: D9 (DEVICE AVAILABLE FOR EVALUATION), H3 (DEVICE EVALUATED BY MANUFACTURER), H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). THE DEVICE OF THE REPORTED ISSUE WAS RETURNED FOR EVALUATION. CUSTOMER REPORT OF "PRESSURE TUBING BECAME DETACHED" WAS UNABLE TO BE CONFIRMED AS PRESSURE LINE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE IV TUBE ADAPTER, WHERE IV TUBE WAS BONDED TO THE MALE CONNECTOR, WAS COMPLETELY BROKEN FROM THE MALE CONNECTOR. THE BROKEN PART OF ADAPTER REMAINED INSIDE OF IV TUBE. CROSS SURFACES OF BROKEN ADAPTOR APPEARED UNEVEN AND ROUGH. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE KIT. BASED ON THE AVAILABLE INFORMATION, THE FAILURE IS ASSOCIATED TO THE SOLVENT EXCESS ON THE IV-SET, IT WAS DETERMINED THAT THIS ISSUE IS POTENTIALLY RELATED TO THE MANUFACTURING PROCESS; THEREFORE, THE MANUFACTURING PERSONNEL HAS BEEN NOTIFIED IN ORDER TO PERFORM AN INVESTIGATION TO AVOID THE RECURRENCE OF THIS ISSUE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.