BLOWER MISTER, 5-PACK
Report
- Report Number
- 2242352-2021-00433
- Event Type
- Malfunction
- Date Received
- May 28, 2021
- Date of Event
- May 7, 2021
- Report Date
- July 1, 2021
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- FQH
- UDI-DI
- 00607567700741
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
TRACKWISE ID # (B)(4).
TRACKWISE # (B)(4). CORRECTED SECTION: H6- INVESTIGATION CONCLUSIONS CORRECT TO "4315", H6- INVESTIGATION FINDINGS CORRECTED TO " "171", CORRECTED H10- SUMMARY, H6- HEALTH EFFECT CODE CORRECTED TO "NO PATIENT INVOLVED" THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 05/24/2021. PHOTOGRAPHS WERE PROVIDED BY THE ACCOUNT. A PHOTOGRAPHIC INSPECTION WAS CONDUCTED. THE OUTER SHIPPING BOX WAS OBSERVED TO BE INTACT, NO VISUAL DEFECTS OBSERVED ON THE SHIPPING BOX. THE PACKAGING BOX WAS OBSERVED TO BE DENTED AND TORN ON THE ONE SIDE. NO OTHER VISUAL DEFECTS WERE OBSERVED. AN INVESTIGATION WAS CONDUCTED ON 06/03/2021. A VISUAL INSPECTION WAS CONDUCTED. THE PACKAGING BOX WAS OBSERVED TO BE DENTED AND TORN ON THE ONE SIDE. THE INDIVIDUAL PACKAGE WAS OBSERVED TO BE INTACT, NO VISUAL DEFECTS WERE OBSERVED. THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED ADVERSE EVENT. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE " MANUFACTURING, PACKAGING OR SHIPPING PROBLEM" WAS CONFIRMED. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE SERIAL/LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS. THE C OF C IS AVAILABLE FOR REVIEW AS AN ATTACHMENT TO THE RECORD.
TRACKWISE # (B)(4). UPDATED SECTION: G4, G7, H2, H3, H6, H10. ANALYSIS OF PRODUCTION: (3331/213/67) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE MANUFACTURING PROCESS AND THE REPORTED FAILURE MODE. HISTORICAL DATA ANALYSIS: (4109/213/67) THE REVIEW OF THE HISTORICAL DATA INDICATES THAT NO OTHER SIMILAR COMPLAINTS WAS REPORTED FOR THE SAME LOT NUMBER AND REPORTED FAILURE MODE. TREND ANALYSIS: (4110/213/67) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD JUN-2019 THROUGH MAY-2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. COMMUNICATION/INTERVIEWS: (4111/213) COMMUNICATION/INTERVIEWS WERE PERFORMED TO OBTAIN ALL POSSIBLE INFORMATION. TESTING OF ACTUAL/SUSPECTED DEVICE (10 &13/22 ) . THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 05/24/2021. PHOTOGRAPHS WERE PROVIDED BY THE ACCOUNT. A PHOTOGRAPHIC INSPECTION WAS CONDUCTED. THE OUTER SHIPPING BOX WAS OBSERVED TO BE INTACT, NO VISUAL DEFECTS OBSERVED ON THE SHIPPING BOX. THE PACKAGING BOX WAS OBSERVED TO BE DENTED AND TORN ON THE ONE SIDE. NO OTHER VISUAL DEFECTS WERE OBSERVED. AN INVESTIGATION WAS CONDUCTED ON (B)(6) 2021. A VISUAL INSPECTION WAS CONDUCTED. THE PACKAGING BOX WAS OBSERVED TO BE DENTED AND TORN ON THE ONE SIDE. THE INDIVIDUAL PACKAGE WAS OBSERVED TO BE INTACT, NO VISUAL DEFECTS WERE OBSERVED. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE " MANUFACTURING, PACKAGING OR SHIPPING PROBLEM" WAS CONFIRMED. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE SERIAL/LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS. THE C OF C IS AVAILABLE FOR REVIEW AS AN ATTACHMENT TO THE RECORD.
GETINGE GROUP TAIWAN CO., LTD. REPORTED THAT CB-1000 WAS RECEIVED ON MAY 07, AND THE OUTSIDE BOX IS FINE CONDITION. BUT THEY FOUND OUT ONE BOX BLOWER MISTER AFTER CB-1000 WITH DENT AND CUSTOMER WON¿T ACCEPT THEM. NO PATIENT INVOLVEMENT. PHOTO PROVIDED.
RELATED TO (B)(4).
RELATED TO (B)(4).
(B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.
RELATED TO 469479, 469482, 469483 AND 469485. (B)(4) REPORTED THAT CB-1000 WAS RECEIVED ON MAY 07, AND THE OUTSIDE BOX IS FINE CONDITION. BUT THEY FOUND OUT ONE BOX BLOWER MISTER AFTER CB-1000 WITH DENT AND CUSTOMER WON¿T ACCEPT THEM. NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 799645 | BLOWER MISTER, 5-PACK | LAVAGE, JET | FQH | MAQUET CARDIOVASCULAR LLC | BLOWER MISTER, 5-PACK | 96255672 | 00607567700741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |