N
Patient 1
(B)(4).
MAUDE MDR 7575433
- MDR report key
- 7575433
- Report number
- 3003925919-2018-00004
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-05-04
- Date received
- 2018-06-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Contact
- CAROL MOORE
- Address
- 2550 STANWELL DRIVE L DRIVE CONCORD CA 94520 US
- Phone
- 925-925-9258
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | INTERCEPT BLOOD SYSTEM FOR PLATELETS | INTERCEPT BLOOD SYSTEM FOR PLATELETS | CERUS CORPORATION | PJF | INT2510 | CE17C24L61 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-06-06 | 0 | 1. L |
Event Narratives#
D
Patient 1
TRANSFUSION TRANSMITTED INFECTION - ACINETOBACTER BAUMANII [TRANSMISSION OF AN INFECTIOUS AGENT VIA PRODUCT]. CASE NARRATIVE: DATE CERUS RECEIVED: 07-MAY-2018, 08-MAY-2018, 09-MAY-2018, 10-MAY-2018, 11-MAY-2018, 14-MAY-2018, 15-MAY-2018, 17-MAY-2018, 21-MAY-2018, 31-MAY-2018, 01-JUN-2018, 03-JUN-2018, 04-JUN-2018, 05-JUN-2018 (IN). PATIENT DEMOGRAPHICS: (B)(6) YEAR-OLD WHITE MALE. PRODUCT COMPLAINT #: (B)(4). PRODUCT ID # (DIN): (B)(4). PROCESSING SET LOT #: CE17C24L61. ILLUMINATOR SERIAL #: (B)(4). ON 07-MAY-2018, CERUS RECEIVED A SPONTANEOUS SERIOUS ADVERSE EVENT REPORT ((B)(4)) FROM DR. (B)(6), THE TRANSFUSION SERVICE MEDICAL DIRECTOR AT THE (B)(6) MEDICAL CENTER VIA A CERUS EMPLOYEE IN THE UNITED STATES. FURTHER INFORMATION ON THE INITIAL REPORT WAS RECEIVED BETWEEN 08-MAY-2018 TO 04-JUN-2018 FROM THE FOLLOWING REPORTERS: DR. (B)(6), CHIEF MEDICAL OFFICER OF THE (B)(6); DR. (B)(6), DIVISIONAL MEDICAL OFFICER, (B)(6); (B)(6), DIRECTOR OF QUALITY ASSURANCE, (B)(6); DR. (B)(6), CHIEF OF MICROBIOLOGY AT (B)(6); DR. (B)(6), DIRECTOR AT (B)(6); AND DR (B)(6), (B)(6). THIS REPORT INVOLVES A (B)(6)-YEAR-OLD WHITE MALE PATIENT WHO EXPERIENCED A SERIOUS ADVERSE EVENT OF TRANSFUSION TRANSMITTED INFECTION - ACINETOBACTER BAUMANII [PT: TRANSMISSION OF AN INFECTIOUS AGENT VIA PRODUCT] FOLLOWING TRANSFUSION OF INTERCEPT PLATELET CONCENTRATES (PC). THE PATIENT?S PRIMARY DIAGNOSIS IS ACUTE LYMPHOBLASTIC LEUKEMIA STATUS POST ALLOGENEIC STEM CELL TRANSPLANT ON (B)(6) 2017. THE PATIENT IS CURRENTLY UNDERGOING CHEMOTHERAPY FOR RELAPSE. CONCURRENT CONDITIONS INCLUDE NEUTROPENIA. [ADDITIONAL CLINICAL INFORMATION, E.G., INDUCTION, CONSOLIDATION, ANC/WBC WILL BE QUERIED AND ADDED AS RECEIVED FROM THE REPORTER.] THE PATIENT IS BLOOD GROUP O, RH NEGATIVE. THE PATIENT?S CONCOMITANT MEDICATIONS INCLUDED CEFAZOLIN. THE PATIENT DID NOT HAVE A REPORTED HISTORY OF TRANSFUSION REACTIONS. ON (B)(6) 2018, THE PATIENT WAS TRANSFERRED TO (B)(6) MEDICAL CENTER FOR LINE-ASSOCIATED (B)(6) BACTEREMIA DUE TO HICKMAN LINE CATHETER INFECTION. THE (B)(6) WAS CONFIRMED WITH A (B)(6) BLOOD CULTURE ON THE SAME DATE. ON (B)(6) 2018, THE PATIENT?S HICKMAN LINE CATHETER WAS REMOVED. ADDITIONAL CULTURES WERE DRAWN ON THE FOLLOWING DAYS AND WERE CONSISTENTLY NEGATIVE: (B)(6) 2018. ON (B)(6) 2018, THE PATIENT EXPERIENCED AN ABSCESS IN HIS RIGHT SHOULDER WHICH REQUIRED INCISION AND DRAINAGE (I & D). THE (B)(6) INFECTION WAS BELIEVED TO BE ASSOCIATED WITH THE ABSCESS IN HIS RIGHT SHOULDER. ON (B)(6) 2018, A SWAB SAMPLE TAKEN FROM THE PATIENT?S RIGHT SHOULDER WAS GRAM STAIN NEGATIVE. [QUERY WILL BE SUBMITTED TO THE REPORTER TO CLARIFY/CONFIRM THE SPECIMEN COLLECTION SITE, E.G., SKIN SURFACE, WOUND, DRAIN, ETC., ON THE RIGHT SHOULDER.] CULTURES REVEALED NO GROWTH. ON THE SAME DATE, A PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) LINE WAS PLACED IN HIS LEFT UPPER ARM. THE SURGICAL WOUND DRAIN WAS REMOVED ON (B)(6) 2018 AND SUTURES REMOVED ON (B)(6) 2018. [QUERY WILL BE SUBMITTED TO THE REPORTER REGARDING CULTURE RESULTS, IF ANY, FROM THE SURGICAL WOUND DRAIN.] ON AN UNSPECIFIED DATE, THE PATIENT WAS TREATED WITH CEFAZOLIN AND RESPONDED WELL TO TREATMENT WITH PLANS FOR DISCHARGE ON (B)(6) 2018. ON (B)(6) 2018 10:46H, A 406 ML PLATELET DONATION WAS COLLECTED AT (B)(6) VIA APHERESIS PROCEDURE ON AN AMICUS INSTRUMENT. THE APHERESIS COLLECTION RUN TIME WAS 100 MINUTES AND SUSPENSION MEDIUM WAS PAS-3. THE DONOR IS A BLOOD TYPE (B)(6); (B)(6) YEAR-OLD FEMALE FREQUENT PLATELET DONOR WITH NO RECORD OF A POSITIVE BACTERIAL SCREENING CULTURE IN THIS OR PRIOR DONATIONS (BACT/ALERT ALARM CODES). SHE DID HAVE A 1 YEAR MALARIA TRAVEL DEFERRAL FROM 2015-2016. IT WAS LATER REVEALED DURING THE (B)(6) DONOR INVESTIGATION THAT THE SHE HAD AN ABDOMINAL RASH AND A HEALING ~1 INCH ABSCESS ON HER BACK AT THE TIME OF DONATION; WHICH SHE DID NOT REPORT DURING ROUTINE DONOR SCREENING. ON THE SAME DATE, THE DONATED UNIT WAS PROCESSED WITH AN INTERCEPT BLOOD SYSTEM DUAL STORAGE (DS) PROCESSING SET. ON (B)(6) 2018, THE DONATED UNIT (DIN: (B)(6)) WAS TREATED WITH THE INTERCEPT BLOOD SYSTEM (TREATMENT TIME: 00:32H ? 00:38H AT (B)(6) APPROXIMATELY 13.5 HOURS AFTER COLLECTION. THE TREATMENT REPORT SHOWED A SUCCESSFUL TREATMENT WITH NO INDICATION OF MALFUNCTION OR IRREGULARITIES. FOLLOWING TREATMENT, THE UNIT WAS SPLIT INTO TWO COMPONENTS: DIN: (B)(6). THE EXPIRATION DATE OF BOTH UNITS WAS 04-MAY-2018. ON (B)(6) 2018 13:00H, THE FIRST COMPONENT (DIN: (B)(4)) WAS SHIPPED FROM (B)(4) DEPOT. AT 16:17H, THE SECOND COMPONENT (DIN: (B)(4)) WAS RECEIVED AT THE (B)(6) DEPOT. ON (B)(6) 2018 13:56H, THE SECOND COMPONENT (DIN: (B)(4)) WAS SHIPPED FROM (B)(4) TO THE (B)(6) DEPOT. AT 15:52H, THE SECOND COMPONENT (DIN: (B)(4)) WAS RECEIVED AT THE (B)(4) DEPOT AND PLACED INTO A CONTROLLED STORAGE ENVIRONMENT. ON 03-MAY-2018 06:57H, THE (B)(6) TRANSFUSION SERVICE RECEIVED THE IMPLICATED UNIT (DIN: (B)(4)) FROM (B)(4). UPON RECEIPT FROM (B)(6), A VISUAL CHECK OF THE BAGS WAS PERFORMED BY (B)(6) BLOOD BA...