N
Patient 1
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.
MAUDE MDR 5413746
- MDR report key
- 5413746
- Report number
- 1722028-2016-00043
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-01-08
- Date received
- 2016-02-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MATTHEW BICKFORD
- Address
- 10810 W COLLINS AVE LAKEWOOD CO 80215 US
- Phone
- 303-303-3032
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HARVEST TERUMO | APC30 PLATELET PROCEDURE PACK | TERUMO BCT | ORG | APC30 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-02-05 | 0 | 1. O |
Event Narratives#
D
Patient 1
THE CUSTOMER REPORTED THAT HER KIT WAS NOT DECANTING WELL. WHILE TROUBLESHOOTING, SHE DISCOVERED THAT THE ANTICOAGULANT HAD EXPIRED IN THE KIT THAT SHE HAD USED. THE CUSTOMER WAS UNABLE TO PROVIDE LOT NUMBER OR EXPIRATION DATE OF THE ANTICOAGULANT THAT WAS USED. THE CUSTOMER WAS ABLE TO WITHDRAW VIABLE PLATELETS FROM THE PRODUCT AND WAS ABLE TO USE THEM FOR THE TREATMENT. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THE KIT IS NOT AVAILABLE FOR RETURN, BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
N
Patient 1
INVESTIGATION: THE DISPOSABLE SETS WERE UNAVAILABLE FOR RETURN FOR ANALYSIS. HARVEST PRODUCT KITS CONTAIN MULTIPLE COMPONENTS THAT HAVE VARIOUS EXPIRY DATES. THE OUTER KIT LABEL CONTAINS THE EXPIRY DATE ASSOCIATED WITH THE COMPONENT THAT HAS THE SHORTEST EXPIRY TIME FRAME. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER THE ANTICOAGULANT USED DURING THE PROCEDURE WAS EXPIRED. THE CUSTOMER WAS NOT ABLE TO PROVIDE THE KIT LOT NUMBER, ANTICOAGULANT BOTTLE LOT NUMBER, NOR THE ANTICOAGULANT BOTTLE EXPIRATION DATE. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED AS IT COULD NOT BE DETERMINED WHY EXPIRED PRODUCT WAS AVAILABLE AT THE CUSTOMER SITE. IT IS POSSIBLE THAT THE OUTER KIT PACKAGING WAS DISCARDED, PRIOR TO USE, WHICH CONTAINED THE CORRECT KIT EXPIRY INFORMATION, BASED ON THE SHORTEST COMPONENT EXPIRATION DATE. INDIVIDUAL COMPONENT EXPIRY LABELING IS PRESENT TO ENSURE USAGE PRIOR TO EXPIRED DATES. THE DEVICE HISTORY RECORD FOR THIS PRODUCT SHOWED ALL PRODUCT PASSED QUALITY LABS AND STERILIZATION REQUIREMENTS.
D
Patient 1
NO MEDICAL INTERVENTION WAS NEEDED FOR THIS EVENT.T HE CUSTOMER DID NOT PROVIDE THE PATIENT'S INFORMATION.