HLS CANNULAE & PIK
Report
- Report Number
- 8010762-2024-00288
- Event Type
- Malfunction
- Date Received
- May 27, 2024
- Report Date
- July 22, 2024
- Manufacturer
- MAQUET CARDIOPULMONARY GMBH
- Product Code
- DWF
- PMA / PMN Number
- K131666
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.
IT WAS REPORTED THAT PACKAGE OF THE PIK 150 WAS BROKEN. THE RECEIVED PHOTOGRAPH OF THE COMPLAINT SHOWS THAT A HOLE ON THE PAPER SIDE OF STERILE PACKAGING. CUSTOMER CHANGED THE PRODUCT BEFORE TREATMENT. NO HARM TO ANY PERSON WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM GETINGE SALES & SERVICE UNIT AS: - THE PRODUCT WAS RE-PACKED BY ANOTHER SUPPLIER IN CHINA, AND ADDITIONAL LABELS WERE ATTACHED ON CARDBOARD BOX AND ON THE MEDICAL PAPER BY THIS SUPPLIER. - THE STORAGE CONDITION INFORMATION COULD NOT BE GATHERED OF HOSPITAL NEITHER THE SUPPLIER. - CUSTOMER COULD NOT ANSWERED AT EXACTLY WHICH SIDE THAT THE STERILE PACKAGE WAS FOLDED. HOWEVER, BASED ON THE RECEIVED PHOTOGRAPH AND VIDEO, THE STERILE PACKAGE OF THE PIK SET WAS FOLDED ON THE WRONG SIDE (FOLDED TO MEDICAL PAPER SIDE) BY CHINA SUPPLIER, FURTHER A CLEAR FOLD MARKS WERE VISIBLE ON THE PAPER SIDE OF THE STERILE PACKAGE. BESIDES, IT IS CLEARLY VISIBLE THAT THE MEDICAL PAPER WAS DAMAGED DUE TO THE WRONG FOLDING SIDE AND ALSO DUE TO THE WRONG PLACED IFUS (DIRECTLY ON MEDICAL PAPER) BY CHINA SUPPLIER. BASED ON THE RECEIVED PHOTOGRAPHICAL EVIDENCE, THE COMPLAINT COULD BE CONFIRMED HOWEVER NOT RELATED WITH PRODUCT. THE PRODUCTION HISTORY RECORD (DHR) OF THE AFFECTED PIK 150#INSERTION KIT, GUIDEWIRE 150 CM WITH LOT# 3000331195 WAS REVIEWED ON 2024-07-09. ACCORDING TO THE DHR RESULT, THE PRODUCT PIK 150#INSERTION KIT, GUIDEWIRE 150 CM PASSED THE DEFINED MANUFACTURING AND FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION ON MANUFACTURING ISSUES. THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. FURTHER, THE INCOMING INSPECTION REPORTS OF THE AFFECTED COMPONENT STERILE BAG / 04187#STERILTÜTE 320 X 500 MM, #700004187 (BATCH # 3000189843) WAS REVIEWED ON 2024-07-09. THE STERILE BAG WAS CHECKED VISUALLY FOR PARTICLES, PUNCTURE, PINHOLE, GAP, TEAR, BURN/MELTDOWN, WRINKLE, STAIN AND SMOOTH SURFACE. ALL TESTS WERE PASSED AS PER SPECIFICATIONS. THE NON-CONFORMITY RECORD REVIEW HAS BEEN PERFORMED FOR THE REPORTED PRODUCT AND FAILURE. THERE COULD NOT BE ANY RECORD THAT COULD CAUSE TO THE FAILURE OF STERILE PACKAGE. BASED ON THE INVESTIGATION RESULTS, THE PROBABLE CAUSE HAS BEEN FOUND AS A WRONG PACKAGING OF THE PRODUCT AFTER SECOND LABELLING BY CHINA SUPPLIER. THE MEDICAL PAPER MIGHT BE DAMAGED DUE TO THE WRONG PACKAGING WITH AN IMPACT OF TRANSPORTATION. THE GETINGE SALES & SERVICE UNIT WILL INFORM SUPPLIER ABOUT THE ISSUE TO REDUCE THE RE-OCCURRENCE. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED FAILURE AND PRODUCT AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING. H3 OTHER TEXT : A PHOTOGRAPHICAL & VIDEO EVIDENCE WAS PROVIDED BY CUSTOMER.
THE CLINICIAN NOTICED PACKAGE OF PIK150 BROKEN. THE RECEIVED PHOTOGRAPH OF THE COMPLAINT SHOWS THAT A HOLE ON THE PAPER SIDE OF STERILE PACKAGING. CUSTOMER CHANGED THE PRODUCT WITHOUT USING IT ON PATIENT. COMPLAINT # (B)(4).
COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1398776 | HLS CANNULAE & PIK | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | DWF | MAQUET CARDIOPULMONARY GMBH | PIK 150#INSERTION KIT, GUIDEWIRE 150 CM | 3000331195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |