MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-08-12 for CASCADE AUTOLOGOUS PLATELET SYSTEM 910046 manufactured by Musculoskeletal Transplant Foundation.
[3762444]
On (b)(6) 2013, three patients underwent prp injections for the treatment of osteoarthritis in the right knee (the injections were performed at the same facility by the same physician). Bilateral knee injections were performed on one of the three patients. The prp was prepared from four individuals, single use cascade kits having the same lot number (107692). It was reported that a few hours after their injections, each patient presented with pain, swelling, and warmth at the injection site, along with severely elevated wbc counts. They were each referred to the emergency room and were diagnosed with "acute right knee effusion/ pain". The patient with the bilateral knee injections did not experience any problems with the left knee. Right knee aspirates were collected from each patient and cultures; all results were reported as negative. Antibiotics were prescribed and the patients were discharged. The physician indicated that "all patients are doing exceptionally well; one has flu-like symptoms and vomiting noted to be from the antibiotics".
Patient Sequence No: 1, Text Type: D, B5
[11049076]
An investigation was performed by a team consisting of representatives from mtf's qa/ ra and r and d departments, as well as, (b)(4) and (b)(4) personnel. It was determined that two lots (2037776 and 2254321) of the yellow top tubes were used to build the subject cascade kits from lot 107692/ product code 910046. According to mtf, tube lot number 2037776 has been ruled out as causing the patient reactions for the following reasons: both yellow top tube lots underwent endotoxin retesting. Lot number 2037776 tested negative and continues to test negative, whereas lot number 2254321 tested positive. Tube lot 2037776 has been used in other kits with no reported adverse reactions, whereas the tubes from lot 2254321 have just begun to be used. One of the three patients had bilateral knee injections using the same kit lot number. Inflammation and pain was reported in one knee and not the other. It is most likely that this clinical outcome suggests that two different tube lots were used. Due to the nature of the complaint report and these findings, mtf advised (b)(4) (distributor) to conduct a recall of the distributed cascade kits having product code 910046/ lot # 107692. In addition, any yellow tubes from lot #2254321 as well as any kits containing tubes with this lot number have been placed in quarantine. Note: the user facility completed a medwatch report (b)(4) and forwarded it to mtf. The report was not sent to fda.
Patient Sequence No: 1, Text Type: N, H10
[6363362]
On (b)(6) 2013, three patients underwent prp injections for the treatment of osteoarthritis in the right knee (the injections were performed at the same facility by the same physician). Bilateral knee injections were performed on one of the three patients. The prp was prepared from four individuals, single use cascade kits having the same lot number (107692). It was reported that a few hours after their injections, each patient presented with pain, swelling, and warmth at the injection site, along with severely elevated wbc counts. They were each referred to the emergency room and were diagnosed with "acute right knee effusion/ pain". The patient with the bilateral knee injections did not experience any problems with the left knee. Right knee aspirates were collected from each patient and cultures; all results were reported as negative. Antibiotics were prescribed and the patients were discharged. The physician indicated that "all patients are doing exceptionally well; one has flu-like symptoms and vomiting noted to be from the antibiotics".
Patient Sequence No: 2, Text Type: D, B5
[14088666]
An investigation was performed by a team consisting of representatives from mtf's qa/ ra and r and d departments, as well as, (b)(4) and (b)(4) personnel. It was determined that two lots (2037776 and 2254321) of the yellow top tubes were used to build the subject cascade kits from lot 107692/ product code 910046. According to mtf, tube lot number 2037776 has been ruled out as causing the patient reactions for the following reasons: both yellow top tube lots underwent endotoxin retesting. Lot number 2037776 tested negative and continues to test negative, whereas lot number 2254321 tested positive. Tube lot 2037776 has been used in other kits with no reported adverse reactions, whereas the tubes from lot 2254321 have just begun to be used. One of the three patients had bilateral knee injections using the same kit lot number. Inflammation and pain was reported in one knee and not the other. It is most likely that this clinical outcome suggests that two different tube lots were used. Due to the nature of the complaint report and these findings, mtf advised (b)(4) (distributor) to conduct a recall of the distributed cascade kits having product code 910046/ lot # 107692. In addition, any yellow tubes from lot #2254321 as well as any kits containing tubes with this lot number have been placed in quarantine. Note: the user facility completed a medwatch report (b)(4) and forwarded it to mtf. The report was not sent to fda.
Patient Sequence No: 2, Text Type: N, H10
[6373623]
On (b)(6) 2013, three patients underwent prp injections for the treatment of osteoarthritis in the right knee (the injections were performed at the same facility by the same physician). Bilateral knee injections were performed on one of the three patients. The prp was prepared from four individuals, single use cascade kits having the same lot number (107692). It was reported that a few hours after their injections, each patient presented with pain, swelling, and warmth at the injection site, along with severely elevated wbc counts. They were each referred to the emergency room and were diagnosed with "acute right knee effusion/ pain". The patient with the bilateral knee injections did not experience any problems with the left knee. Right knee aspirates were collected from each patient and cultures; all results were reported as negative. Antibiotics were prescribed and the patients were discharged. The physician indicated that "all patients are doing exceptionally well; one has flu-like symptoms and vomiting noted to be from the antibiotics".
Patient Sequence No: 3, Text Type: D, B5
[14233475]
An investigation was performed by a team consisting of representatives from mtf's qa/ ra and r and d departments, as well as, (b)(4) and (b)(4) personnel. It was determined that two lots (2037776 and 2254321) of the yellow top tubes were used to build the subject cascade kits from lot 107692/ product code 910046. According to mtf, tube lot number 2037776 has been ruled out as causing the patient reactions for the following reasons: both yellow top tube lots underwent endotoxin retesting. Lot number 2037776 tested negative and continues to test negative, whereas lot number 2254321 tested positive. Tube lot 2037776 has been used in other kits with no reported adverse reactions, whereas the tubes from lot 2254321 have just begun to be used. One of the three patients had bilateral knee injections using the same kit lot number. Inflammation and pain was reported in one knee and not the other. It is most likely that this clinical outcome suggests that two different tube lots were used. Due to the nature of the complaint report and these findings, mtf advised (b)(4) (distributor) to conduct a recall of the distributed cascade kits having product code 910046/ lot # 107692. In addition, any yellow tubes from lot #2254321 as well as any kits containing tubes with this lot number have been placed in quarantine. Note: the user facility completed a medwatch report (b)(4) and forwarded it to mtf. The report was not sent to fda.
Patient Sequence No: 3, Text Type: N, H10
| Report Number | 2249062-2013-00002 |
| MDR Report Key | 3287182 |
| Report Source | 05,08 |
| Date Received | 2013-08-12 |
| Date of Report | 2013-08-12 |
| Date of Event | 2013-07-15 |
| Date Mfgr Received | 2013-07-16 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2013-08-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NINA ONYSZCZUK |
| Manufacturer Street | 175 MAY STREET |
| Manufacturer City | EDISON NJ 08837 |
| Manufacturer Country | US |
| Manufacturer Postal | 08837 |
| Manufacturer Phone | 7326614064 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASCADE AUTOLOGOUS PLATELET SYSTEM |
| Generic Name | CASCADE AUTOLOGOUS PLATELET SYSTEM - PRP |
| Product Code | KSS |
| Date Received | 2013-08-12 |
| Model Number | 910046 |
| Lot Number | 107692 (4 KITS) |
| Device Expiration Date | 2014-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| Manufacturer Address | 175 MAY STREET EDISON NJ 08837 US 08837 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-12 | |
| 2 | 0 | 2013-08-12 | |
| 3 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2013-08-12 |