BLOWER MISTER, 5-PACK
Report
- Report Number
- 2242352-2021-00434
- Event Type
- Malfunction
- Date Received
- May 28, 2021
- Date of Event
- May 7, 2021
- Report Date
- July 7, 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
UPDATED SECTIONS: G4,G7,H2,H10,H11. H10 CORRECTION: TREND ANALYSIS AND TESTING OF ACTUAL/SUSPECTED DEVICE HAS BEEN CORRECTED. INTERNAL COMPLAINT NUMBER: (B)(4). TREND ANALYSIS: (4110/213) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD JUN 2019 THROUGH MAY 2021 WAS REVIEWED. RUN RULE WAS TRIGGERED FOR THE MONTH OF MAY 2021. THE TRIGGER IS ADDRESSED UNDER CAPA REQUEST. THE CAPA REQUEST IS CLOSED. TESTING OF ACTUAL/SUSPECTED DEVICE: (10/171/4315) THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON (B)(6) 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. 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 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.
INTERNAL COMPLAINT NUMBER: (B)(4). ANALYSIS OF PRODUCTION: (3331/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WERE 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 BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE. HISTORICAL DATA ANALYSIS: (4109/213) THERE WERE 04 ADDITIONAL SIMILAR COMPLAINT(S) REPORTED FOR THE REPORTED FAILURE MODE AND THE REPORTED LOT/SERIAL NUMBER. A REVIEW OF THE PRODUCT COMPLAINT TREND DATA WAS PERFORMED FOR THE MONTHS OF "FEB 2021¿ THROUGH ¿MAY 2021¿. THE REVIEW DOES NOT IDENTIFY AN INCREASING TREND OR AN ADVERSE TREND FOR THREE CONSECUTIVE MONTHS FOR THE PRODUCT FAMILY AND THE FAILURE MODE. TREND ANALYSIS: (4110/213) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD JUN 2019 THROUGH MAY 2021 WAS REVIEWED. RUN RULE WAS TRIGGERED FOR THE MONTH OF MAY 2021. THE TRIGGER IS ADDRESSED UNDER CRF. TESTING OF ACTUAL/SUSPECTED DEVICE: (10/171/4315) 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 INTERNAL CONTENTS OF THE SHIPPING BOX WERE NOT OBSERVED IN THE PHOTOGRAPHS. 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. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURE " MANUFACTURING, PACKAGING OR SHIPPING PROBLEM" WAS CONFIRMED.
H10 CORRECTION: SUMMARY HAS BEEN CORRECTED. TESTING OF ACTUAL/SUSPECTED DEVICE: (10/171/4315) 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. 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. 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 LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS.
UPDATED SECTION: D-10, G-4, G-7, H-2, H-10, H-11. CORRECTED SECTION B-5 TO REFLECT THE UPDATED INFORMATION. CORRECTED SECTION: H-3 DEVICE NOT EVAL PROVIDE CODE: FROM "OTHER" TO "DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN." TRACKWISE ID # 469479.
N/A.
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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 WAS PROVIDED.
(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. DEVICE NOT RETURNED.
RELATED TO 467378, 469482, 469483 AND 469485. (B)(4) REPORTED THAT CB-1000 WAS RECEIVED ON (B)(6) 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 |
|---|---|---|---|---|---|---|---|
| 799649 | BLOWER MISTER, 5-PACK | LAVAGE, JET | FQH | MAQUET CARDIOVASCULAR LLC | BLOWER MISTER, 5-PACK | 96255672 | 00607567700741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |