MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2014-12-17 for CELSIOR (CELSIOR ORGAN PRESERVATION SOLUTION) manufactured by Genzyme Polyclonals S.a.s..
[16892355]
This unsolicited device case from (b)(6) was received on (b)(6) 2014 from a pharmacist. This case involves a patient (demographics unspecified) who underwent transplantation with organ dispatched in celsior organ preservation solution (celsior) from a batch which was positive for sphingomonas paucimobilis/bacteria were identified. No past drugs, medical history or concurrent conditions were reported. On (b)(6) 2014 (during the night), liver, kidneys, and lungs were taken from one unique female patient who died from cerebral aneurysm rupture. She had no systemic infection except mention of an e coli urinary tract infection (uti). On an unknown date, the organs were preserved in celsior, solution for organ preservation for transplantation. It was reported that the organs were dispatched in 3 different batches of celsior organ preservation solution (batch: date: jul-2015; batch: 392, expiration date: oct-2015). It was reported that 02 samples from 02 of 03 batches were taken for examination. On an unspecified date, the patient was transplanted with the organ preserved in celsior organ preservation solution whose bacteriological culture was found positive for pseudomonas aeruginosa/pyocyanic bacillus (batch unknown). It was reported that the patient received accurate prophylactic antibiotics and no consequence was reported in the patient. It was reported that all packs of batch 381 still present at the hospital were kept in quarantine, but there was no remaining pack of batch 371. No information was available on pack 392. At the time of reporting, investigations were ongoing to determine the origin of the bacteria found on blood culture. Further reported that the bacteria were identified as sphingomonas paucimobilis which according to the team in charge in the hospital was due to contamination and the method of sampling in the hospital had been reviewed. It was also reported that culture done on (b)(6) 2014, on one of the suspected batches kept in quarantine were awaited. No more information was available. Outcome: unk. Seriousness criteria: important medical event. A pharmaceutical technical complaint (ptc) was initiated and global ptc number: (b)(4) and results were pending.
Patient Sequence No: 1, Text Type: D, B5
[17270066]
Additional information was received on (b)(4) 2014 (both the information's were processed together with clock start date: (b)(4) 2014). Global ptc number was added. Event verbatim updated from transplantation with organ dispatched in celsior organ preservation solution (celsior) from a batch which was positive for pseudomonas aeruginosa to transplantation with organ dispatched in celsior organ preservation solution (celsior) from a batch which was positive for pseudomonas aeruginosa to transplantation with organ dispatched in celsior organ preservation solution (celsior) from a batch which was positive for sphingomonas paucimobilis/bacteria were identified. Laboratory data added. Patient clinical course updated and text was amended accordingly. Pharmacovigilance comment: sanofi company follow up comment dated (b)(4) 2014: according to the follow up information received, culture was found to be positive with sphingomonas paucimobilis instead of pseudomonas aeruginosa. Sanofi company comment dated: (b)(4) 2014: this initial case is regarding celsior which is used for organ preservation in which blood culture was found to be positive with pseudomonas aeruginosa and the preserved organ was transplanted in patient. The causal roll of celsior cannot be completely denied for the event. However, information was not available on time when sample was taken (before or after organ infusion). Also, patient whose organs were taken was suffering from e coli urinary tract infection. Furthermore, investigations are still ongoing to determine the origin of the bacteria. Therefore, with the available information it is difficult to provide the complete case assessment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2950168-2014-70404 |
| MDR Report Key | 4359707 |
| Report Source | 01,05 |
| Date Received | 2014-12-17 |
| Date of Report | 2014-12-08 |
| Date of Event | 2014-12-01 |
| Date Mfgr Received | 2014-12-08 |
| Date Added to Maude | 2014-12-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | KRISTEN SHARMA, MD |
| Manufacturer Street | 55 CORPORATE DRIVE MAIL STOP: 55C-235A |
| Manufacturer City | BRIDGEWATER NJ 08807 |
| Manufacturer Country | US |
| Manufacturer Postal | 08807 |
| Manufacturer Phone | 9089812784 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELSIOR (CELSIOR ORGAN PRESERVATION SOLUTION) |
| Generic Name | ORGAN PRESERVATION SOLUTION |
| Product Code | MSB |
| Date Received | 2014-12-17 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENZYME POLYCLONALS S.A.S. |
| Manufacturer Address | LYON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-17 |