8010762-2019-00073
Report
- Report Number
- 8010762-2019-00073
- Event Type
- Malfunction
- Date Received
- March 19, 2019
- Date of Event
- February 21, 2019
- Report Date
- March 18, 2019
- PMA / PMN Number
- K080592
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
(B)(4). REFERENCE EXEMPTION # E2018002. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). MAQUET CARDIOPULMONARY (B)(4) REQUESTED THE PRODUCT FOR INVESTIGATION BUT THE PRODUCT WAS NOT AVAILABLE. ALREADY SCRAPPED BY THE CUSTOMER. THEREFORE NO LABORATORY INVESTIGATION COULD BE PERFORMED BY THE MANUFACTURER. A REVIEW FOR SIMILAR COMPLAINTS TO BE INVESTIGATED ALREADY WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND. THUS THE REPORTED FAILURE COULD NOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE AT THIS TIME THE CAUSE OF THIS FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. SINCE THE REPORTED FAILURE DID NOT CONTRIBUTE TO A DEATH OR SERIOUS INJURY NO CORRECTIVE ACTION IS NEEDED. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT THIS IS A SYSTEMIC ERROR. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.
ACCORDING TO THE CUSTOMER: PERFUSIONIST CLAIMED THE DISPOSABLE WAS LEAKING. ADDITIONAL INFORMATION: LEAKAGE OCCURRED AFTER ONE DAY IN USE ON THE PUMP HOUSING. CUSTOMER REPLACED THE CIRCUIT WITH A NEW HLS SET AND FINISHED THE CASE. NO HARM TO THE PATIENT WAS REPORTED. (B)(4).
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |