MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-09-06 for ACP?215 AUTOMATED CELL PROCESSOR 02215-220-E manufactured by Haemonetics Corp.
[53945028]
A haemonetics field service engineer (fse) evaluated the device. Several procedures were completed with no issues. The fse was not able to confirm the reported defect. The device was put through diagnostic testing and all tests were within manufacturer specifications. The evaluation of the bowl has not been completed. A supplemental report will be sent once the investigation is final.
Patient Sequence No: 1, Text Type: N, H10
[53945029]
Haemonetics received a report stating that on (b)(6) 2016 during use of the acp5 automated cell processor, the operator experienced a very noisy bowl during process. The customer states the bowl was apparently properly installed, no leak, no alarm. The user was sent to ent emergency service, with tinnitus, pain, deafness. Symptoms lasted 9-12 hours. Corticoid treatment was prescribed. Following the incident, the operator developed a cold resulting in an ear infection which made the initial symptoms worse and slowed the recovery process. As of (b)(6) 2016, the operator had made a full recovery with no permanent results.
Patient Sequence No: 1, Text Type: D, B5
[59984891]
The bowl that was used in the reported issue was returned for testing. The bowl passed spin testing through all cycles per haemonetics standard procedures. With the bowl properly aligned and fully seated in the centrifuge chuck, the bowl functioned as intended with no functional defects found. The bowl had no audible noise and maintained its initial seating in the centrifuge chuck throughout the entire simulated procedure. Dimensions critical to the bowl maintaining seating in the centrifuge chuck were measured to specifications and the bowl body and center register were within tolerance. The visual inspection found the bowl had heavy abrasions on the seal crown and header shield skirt. The abrasions indicate that the bowl was improperly seated or poorly aligned in the centrifuge, causing the header shield skirt to come in contact with the seal crown. Abrasions occurred by the bowl spinning while the header shield skirt and seal crown were in contact with each other. Although abrasions on the bowl were found, the functional testing could not replicate this defect and the complaint is not confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219343-2016-00060 |
| MDR Report Key | 5928900 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-09-06 |
| Date of Report | 2016-08-09 |
| Date of Event | 2016-07-28 |
| Date Mfgr Received | 2016-11-14 |
| Device Manufacturer Date | 2007-09-28 |
| Date Added to Maude | 2016-09-06 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS JULIE SMITH, RN |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer Phone | 7819170643 |
| Manufacturer G1 | HAEMONETICS CORP |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02184 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACP?215 AUTOMATED CELL PROCESSOR |
| Generic Name | ACP215 |
| Product Code | KSW |
| Date Received | 2016-09-06 |
| Returned To Mfg | 2016-08-18 |
| Catalog Number | 02215-220-E |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORP |
| Manufacturer Address | 400 WOOD RD BRAINTREE MA 02184 US 02184 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 235 | 1. Required No Informationntervention | 2016-09-06 |